Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02909959
• Collaborator: North Carolina Translational and Clinical Sciences Institute (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The aim of this randomized controlled trial is to determine if a nutritional supplement containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such as hyperactivity, irritability, and repetitive movements.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder; Autistic Disorder; Neurodevelopmental Disorder; Childhood Developmental Disorders, Pervasive	Drug: Sulforaphane; Drug: Placebo	Phase 2

Detailed Description

Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting 1 in 68 children, including 1 in 42 boys, characterized by marked social communication impairment and restricted, repetitive behaviors and interests. Evidence-based pharmacological treatments available for the treatment of the defining symptoms of ASD are currently lacking.

While the etiology of ASD is not fully understood, the pathogenesis is hypothesized to involve cellular dysfunction, including increased oxidative stress, aberrant neuroinflammation, and reduced mitochondrial capacity, leading to synaptic dysfunction in at least a subset of individuals. Sulforaphane is a powerful upregulator of antioxidant response elements and heat shock proteins, which may lead to improved redox capacity, decreased inflammation, and improved mitochondrial functioning in individuals with ASD. A trial by Singh and colleagues (2014) provided preliminary evidence suggesting that sulforaphane derived from broccoli sprout extract can have beneficial effects for improving symptoms of autism.

In this study, young men ages 13-30 years old with moderate to severe autism spectrum disorder will be randomly assigned to receive either a sulforaphane supplement or placebo for a 12 week treatment treatment period, followed by a 4 week blinded discontinuation phase. The uncoated tablets each contain 125 mg broccoli seed extract and 50 mg broccoli sprout extract, corresponding to approximately 15 µmol sulforaphane per tablet. The dose will vary from 3-8 tablets daily depending upon the participant's weight. Matched placebo tablets contain only inert ingredients

A serum sample will be collected prior to starting treatment and at the end of the treatment phase to quantify sulforaphane metabolites. Clinical response will be assessed through clinician- and caregiver-rated measures of autism symptoms (Social Responsiveness Scale-2; Repetitive Behavior Scale- Revised), challenging symptoms commonly observed in individuals with developmental disabilities (Aberrant Behavior Checklist), and global severity of symptoms and improvement (Clinical Global Impression Scale). A blood sample will be collected at baseline and at the end of the treatment phase to check safety labs, and a saliva sample will be collected at baseline for a future study of genetic biomarkers associated with treatment response.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-blind, Placebo-controlled Study of Myrosinase-enriched Glucoraphanin, a Sulforaphane Precursor System, in Autism Spectrum Disorder
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: May 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sulforaphane Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Drug: Sulforaphane; The investigational medicinal product is an uncoated tablet containing both glucoraphanin and myrosinase, the enzyme that converts glucoraphanin to sulforaphane in vivo. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.; Other Names: Avmacol glucoraphanin
Placebo Comparator: Placebo Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.	Drug: Placebo; Placebo tablets are uncoated and matched in appearance to the investigational medicinal product, containing inert components. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.; Other Names: Control

Outcome Measures

Primary Outcome Measures

1. Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline [Baseline]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

2. Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4 [Week 4]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

3. Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8 [Week 8]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

4. Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12 [Week 12]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

5. Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16 [Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.

Secondary Outcome Measures

1. Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Awareness subscale measures a participant's ability to recognize social cues. This subscale comprises 8 items with scores ranging from 1 to 4 for a total range of scores from 8 to 32. A higher score represents a greater ability to recognize social cues. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

2. Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Cognition subscale measures a participant's ability to interpret social behavior. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater ability to interpret social behaviors. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

3. Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Communication subscale measures a participant's ability to assess reciprocal communication in social situations. This subscale comprises 22 items with scores ranging from 1 to 4 for a total range of scores from 22 to 88. A higher score represents a greater ability to assess reciprocal communication. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

4. Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Motivation subscale measures the degree to which a participant is motivated to participate in social interactions. This subscale comprises 11 items with scores ranging from 1 to 4 for a total range of scores from 11 to 44. A higher score represents a greater motivation to participate in social interaction. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

5. Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Restricted Interests/Repetitive Behaviors subscale assesses the participant's level of stereotypy and circumscribed interests. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater level of stereotypy and circumscribed interests. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

6. Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Social Withdrawal subscale assesses the participant's level social withdrawal. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of social withdrawal. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

7. Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Hyperactivity subscale assesses the participant's level hyperactivity and non-compliance. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of hyperactivity/non-compliance. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

8. Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Inappropriate Speech subscale assesses the participant's use of inappropriate speech. This subscale comprises 4 items with scores ranging from 0 to 3 for a total range of scores from 0 to 12. A higher score represents a greater use of inappropriate speech. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

9. Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy) [Baseline, Week 4, Week 8, Week 12, Week 16]

   The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Stereotypy subscale assesses the participant's level of stereotypic behavior. This subscale comprises 7 items with scores ranging from 0 to 3 for a total range of scores from 0 to 21. A higher score represents a greater level of stereotypic behavior. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

10. Aberrant Behavior Checklist (ABC) Subscale Score (Irritability) [Baseline, Week 4, Week 8, Week 12, Week 16]

    The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Irritability subscale assesses the participant's level of irritability. This subscale comprises 15 items with scores ranging from 0 to 3 for a total range of scores from 0 to 45. A higher score represents a greater level of irritability. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

11. Clinical Global Impression-Severity (CGI-S) Score [Baseline, Week 4, Week 8, Week 12, Week 16]

    The CGI-Severity (CGI-S) scale is a 7-point, clinician-rated scale providing an overall assessment of patient functioning relative to other patients with a similar diagnosis (1=not at all ill to 7=severely ill). A higher score indicates a higher level of severity of psychopathology. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

12. Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved [Week 4, Week 8, Week 12, Week 16]

    The clinician-rated CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. The CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. Possible scores on this scale range from 1-6 with the following assigned values: 1 = "Very Much Improved"; 2 = "Much Improved; 3 = "Minimally improved"; 4 = "No change"; 5 = "Minimally worse"; 6= "Much worse." A higher score indicates worsening of illness (ie, ASD), whereas a lower score indicates improvement of illness. This scale was measured at Week 4, Week 8, Week 12, and Week 16. In this measure, the number of participants in each treatment arm determined by the study physician to be "Much Improved" or "Very Much Improved" (indicative of meaningful clinical improvement) were counted.

13. Repetitive Behavior Scale-Revised (RBSR) Total Score [Baseline, Week 4, Week 8, Week 12, Week 16]

    The RBS-R is a 43-item, informant-based questionnaire designed to quantify a range of restricted, repetitive behaviors (RRB) observed in ASD. Scores for each item range from 0 = "Behavior does not occur" to 3 = "Behavior occurs and is a severe problem". Thus the total range is 0 to 129. A higher score indicates a higher breadth of repetitive behaviors. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

14. Mean Red Blood Cell Value [Baseline, Week 12]

    This measure assesses the red blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

15. Mean White Blood Cell Value [Baseline, Week 12]

    This measure assesses the white blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

16. Mean Hemoglobin Value [Baseline, Week 12]

    This measure assesses the hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

17. Mean Hematocrit Value [Baseline, Week 12]

    This measure assesses the hematocrit value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

18. Mean Corpuscular Volume Value [Baseline, Week 12]

    This measure assesses the mean corpuscular volume value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

19. Mean Corpuscular Hemoglobin Value [Baseline, Week 12]

    This measure assesses the mean corpuscular hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

20. Mean Corpuscular Hemoglobin Concentration Value [Baseline, Week 12]

    This measure assesses the mean corpuscular hemoglobin concentration value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

21. Mean Red Blood Cell Distribution Width Value [Baseline, Week 12]

    This measure assesses the red blood cell distribution width value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

22. Mean Platelets Value [Baseline, Week 12]

    This measure assesses the platelets value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

23. Mean Absolute Neutrophils Value [Baseline, Week 12]

    This measure assesses the absolute neutrophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

24. Mean Absolute Lymphocytes Value [Baseline, Week 12]

    This measure assesses the absolute lymphocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

25. Mean Absolute Monocytes Value [Baseline, Week 12]

    This measure assesses the absolute monocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

26. Mean Absolute Eosinophils Value [Baseline, Week 12]

    This measure assesses the absolute eosinophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

27. Mean Absolute Basophils Value [Baseline, Week 12]

    This measure assesses the absolute basophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.

28. Mean Serum Chemistries (Sodium) [Baseline, Week 12]

    This measure assesses the change in the patient's sodium levels. This serum chemistry level was measured at Baseline and Week 12.

29. Mean Serum Chemistries (Potassium) [Baseline, Week 12]

    This measure assesses the change in the patient's potassium levels. This serum chemistry level was measured at Baseline and Week 12.

30. Mean Serum Chemistries (Chloride) [Baseline, Week 12]

    This measure assesses the change in the patient's chloride levels. This serum chemistry level was measured at Baseline and Week 12.

31. Mean Serum Chemistries (Bicarbonate) [Baseline, Week 12]

    This measure assesses the change in the patient's bicarbonate levels. This serum chemistry level was measured at Baseline and Week 12.

32. Mean Serum Chemistries (Blood Urea Nitrogen) [Baseline, Week 12]

    This measure assesses the change in the patient's blood urea nitrogen levels. This serum chemistry level was measured at Baseline and Week 12.

33. Mean Serum Chemistries (Creatinine) [Baseline, Week 12]

    This measure assesses the change in the patient's creatinine levels. This serum chemistry level was measured at Baseline and Week 12.

34. Mean Serum Chemistries (Glucose) [Baseline, Week 12]

    This measure assesses the change in the patient's glucose levels. This serum chemistry level was measured at Baseline and Week 12.

35. Mean Liver Function Tests Values (Alanine Transaminase) [Baseline, Week 12]

    This measure assesses the change in the patient's level of liver function through measure of alanine transaminase (ALT). This liver function test value was measured at Baseline and Week 12.

36. Mean Liver Function Tests Values (Aspartate Transaminase) [Baseline, Week 12]

    This measure assesses the change in the patient's level of liver function through measure of aspartate transaminase. This liver function test value was measured at Baseline and Week 12.

37. Mean Liver Function Tests Values (Total Bilirubin) [Baseline, Week 12]

    This measure assesses the change in the patient's level of liver function through measure of total bilirubin. This liver function test value was measured at Baseline and Week 12.

38. Mean Value of Thyroid Stimulating Hormone (TSH) [Baseline, Week 12]

    This measure assesses the change in the patient's value of thyroid stimulating hormone. This hormone value was measured at Baseline and Week 12.

39. Least Squares Mean of Vital Signs (Weight) [Baseline, Week 4, Week 8, Week 12, Week 16]

    This measure assesses the change in the patient's weight (lbs). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

40. Least Squares Mean of Vital Signs (Height) [Baseline, Week 4, Week 8, Week 12, Week 16]

    This measure assesses the change in the patient's height (centimeters). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

41. Least Squares Mean of Vital Signs (Blood Pressure) [Baseline, Week 4, Week 8, Week 12, Week 16]

    This measure assesses the change in the patient's systolic and diastolic blood pressure. This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

42. Least Squares Mean of Vital Signs (Heart Rate) [Baseline, Week 4, Week 8, Week 12, Week 16]

    This measure assesses the change in the patient's heart rate (beats per minute). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males between ages 13-30 (inclusive) at the time of the consent

• Primary diagnosis of Autism Spectrum Disorder (ASD), confirmed by Diagnostic and Statistical Manual-5 (DSM-5) criteria and meeting the autism cut-off score of 9 or greater on the Autism Diagnostic Observation Schedule-2 (ADOS-2)

• Participant is capable of giving written informed consent or has a legally authorized representative (LAR) with sufficient capacity to provide written informed consent on the participant's behalf.

• Participant has a reliable informant (parent or caregiver) who has sufficient past and current knowledge of the subject and will oversee the administration of study medication and accompany the subject to each study visit.

• Participant and caregiver have reliable means of transportation to attend study visits.

Exclusion Criteria:

• Chronic medical illness that is not stable or would pose a risk to the participant if he participates in the trial

• History of clinical seizures within the 12 months preceding study enrollment

• Known genetic disorder that is presumed to be the cause of autism spectrum disorder (eg., Fragile x syndrome, tuberous sclerosis)

• Changes to psychopharmacological medications (e.g., stimulants, antidepressants, anxiolytics, antipsychotics) in the 4 weeks preceding study enrollment

• Significant changes to non-pharmacological treatments for ASD in the 4 weeks preceding study enrollment

• Chronic treatment with anti-inflammatory agents (e.g., ibuprofen, NSAIDs, corticosteroids)

• Clinically significant laboratory abnormalities at Screening visit (e.g., AST/ALT> two times the upper normal limits; serum creatinine > 1.2 mg/dl, TSH outside normal limits)

• Clinically significant findings on physical examination that investigator determines could increase risk of harm from participating in the study

• Participated in another clinical interventional trial or received an investigational product in the 30 days preceding study enrollment

• Previous therapeutic trial of sulforaphane or participation in a clinical trial in which sulforaphane was the investigational agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Institute for Developmental Disabilities, University of North Carolina School of Medicine	Carrboro	North Carolina	United States	27510

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• North Carolina Translational and Clinical Sciences Institute

Investigators

• Principal Investigator: Laura Politte, M.D., University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 14, 2017

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02909959
• Other Study ID Numbers: 16-2059; 5KL2TR001109-05
• First Posted: Sep 21, 2016
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: sulforaphane; glucoraphanin; physiologic effects of drugs
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Developmental Disabilities; Sulforaphane

Study Results

Participant Flow

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Period Title: Overall Study
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sulforaphane	Placebo	Total
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.	Total of all reporting groups
Overall Participants	24	24	48
Age (Count of Participants)
<=18 years	16 66.7%	15 62.5%	31 64.6%
Between 18 and 65 years	8 33.3%	9 37.5%	17 35.4%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.8 (3.9)	17.7 (4.1)	17.2 (4.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	24 100%	24 100%	48 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.2%	2 8.3%	3 6.3%
Not Hispanic or Latino	23 95.8%	22 91.7%	45 93.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 8.3%	0 0%	2 4.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 4.2%	2 8.3%	3 6.3%
White	19 79.2%	21 87.5%	40 83.3%
More than one race	2 8.3%	1 4.2%	3 6.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	24 100%	24 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Least Squares Mean (Standard Error) [T-score]	75.6 (7.4)	72.6 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sulforaphane, Placebo
	Comments	The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
	Type of Statistical Test	Equivalence
	Comments	Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis	p-Value	0.331
	Comments	The test was considered statistically significant if the p-value < 0.05.
	Method	Mixed Models Analysis
	Comments	Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.96
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.03
	Estimation Comments	This analysis compares LS Mean Sulforaphane - LS Mean Placebo.

2. Primary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Least Squares Mean (Standard Error) [T-score]	74.1 (7.4)	74.1 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sulforaphane, Placebo
	Comments	The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
	Type of Statistical Test	Equivalence
	Comments	Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis	p-Value	0.98
	Comments	The test was considered statistically significant if the p-value < 0.05.
	Method	Mixed Models Analysis
	Comments	Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.99
	Estimation Comments	This analysis compares LS Mean Sulforaphane - LS Mean Placebo.

3. Primary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Least Squares Mean (Standard Error) [T-score]	73.7 (7.4)	74.5 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sulforaphane, Placebo
	Comments	The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
	Type of Statistical Test	Equivalence
	Comments	Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis	p-Value	0.797
	Comments	The test was considered statistically significant if the p-value < 0.05.
	Method	Mixed Models Analysis
	Comments	Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.774
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.99
	Estimation Comments	This analysis compares LS Mean Sulforaphane - LS Mean Placebo.

4. Primary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Least Squares Mean (Standard Error) [T-score]	75.3 (7.4)	72.9 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sulforaphane, Placebo
	Comments	The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
	Type of Statistical Test	Equivalence
	Comments	Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis	p-Value	0.442
	Comments	The test was considered statistically significant if the p-value < 0.05.
	Method	Mixed Models Analysis
	Comments	Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.32
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.01
	Estimation Comments	This analysis compares LS Mean Sulforaphane - LS Mean Placebo.

5. Primary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Least Squares Mean (Standard Error) [T-score]	75.5 (7.4)	72.7 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sulforaphane, Placebo
	Comments	The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.
	Type of Statistical Test	Equivalence
	Comments	Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.
Statistical Test of Hypothesis	p-Value	0.373
	Comments	The test was considered statistically significant if the p-value < 0.05.
	Method	Mixed Models Analysis
	Comments	Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.72
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.05
	Estimation Comments	This analysis compares LS Mean Sulforaphane - LS Mean Placebo.

6. Secondary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness)
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Awareness subscale measures a participant's ability to recognize social cues. This subscale comprises 8 items with scores ranging from 1 to 4 for a total range of scores from 8 to 32. A higher score represents a greater ability to recognize social cues. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	10.9 (2.5)	10.9 (1.6)
Week 4	10.5 (2.5)	11.3 (1.6)
Week 8	10.6 (2.5)	11.3 (1.6)
Week 12	10.8 (2.5)	11.0 (1.6)
Week 16	10.7 (2.5)	11.2 (1.6)

7. Secondary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition)
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Cognition subscale measures a participant's ability to interpret social behavior. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater ability to interpret social behaviors. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	19.1 (4.1)	17.4 (2.6)
Week 4	18.3 (4.1)	18.2 (2.6)
Week 8	18.2 (4.1)	18.4 (2.6)
Week 12	18.7 (4.1)	17.9 (2.6)
Week 16	18.7 (4.1)	17.9 (2.6)

8. Secondary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication)
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Communication subscale measures a participant's ability to assess reciprocal communication in social situations. This subscale comprises 22 items with scores ranging from 1 to 4 for a total range of scores from 22 to 88. A higher score represents a greater ability to assess reciprocal communication. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	34.0 (6.6)	32.0 (4.1)
Week 4	32.4 (6.6)	33.6 (4.1)
Week 8	32.6 (6.6)	33.5 (4.1)
Week 12	34.1 (6.6)	32.0 (4.1)
Week 16	34.4 (6.6)	31.7 (4.1)

9. Secondary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation)
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Motivation subscale measures the degree to which a participant is motivated to participate in social interactions. This subscale comprises 11 items with scores ranging from 1 to 4 for a total range of scores from 11 to 44. A higher score represents a greater motivation to participate in social interaction. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	15.5 (4.1)	14.7 (2.5)
Week 4	14.8 (4.1)	15.4 (2.5)
Week 8	14.6 (4.1)	15.6 (2.5)
Week 12	15.5 (4.1)	14.7 (2.5)
Week 16	15.9 (4.1)	14.3 (2.5)

10. Secondary Outcome

Title	Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors)
Description	The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Restricted Interests/Repetitive Behaviors subscale assesses the participant's level of stereotypy and circumscribed interests. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater level of stereotypy and circumscribed interests. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	18.6 (4.5)	17.6 (2.8)
Week 4	18.1 (4.5)	18.2 (2.8)
Week 8	17.7 (4.5)	18.5 (2.8)
Week 12	18.7 (4.5)	17.5 (2.8)
Week 16	18.5 (4.5)	17.7 (2.8)

11. Secondary Outcome

Title	Aberrant Behavior Checklist (ABC) Subscale Score (Social Withdrawal)
Description	The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Social Withdrawal subscale assesses the participant's level social withdrawal. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of social withdrawal. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	8.7 (5.1)	8.3 (3.2)
Week 4	8.2 (5.1)	8.8 (3.2)
Week 8	8.2 (5.1)	8.8 (3.2)
Week 12	9.0 (5.1)	8.1 (3.2)
Week 16	9.5 (5.1)	7.5 (3.2)

12. Secondary Outcome

Title	Aberrant Behavior Checklist (ABC) Subscale Scores (Hyperactivity)
Description	The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Hyperactivity subscale assesses the participant's level hyperactivity and non-compliance. This subscale comprises 16 items with scores ranging from 0 to 3 for a total range of scores from 0 to 48. A higher score represents a greater level of hyperactivity/non-compliance. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	14.3 (5.7)	10.8 (3.6)
Week 4	13.0 (5.7)	12.1 (3.6)
Week 8	12.6 (5.7)	12.5 (3.6)
Week 12	13.7 (5.7)	11.3 (3.6)
Week 16	13.6 (5.7)	11.5 (3.6)

13. Secondary Outcome

Title	Aberrant Behavior Checklist (ABC) Subscale Score (Inappropriate Speech)
Description	The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Inappropriate Speech subscale assesses the participant's use of inappropriate speech. This subscale comprises 4 items with scores ranging from 0 to 3 for a total range of scores from 0 to 12. A higher score represents a greater use of inappropriate speech. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	3.4 (1.7)	2.8 (1.1)
Week 4	3.2 (1.7)	2.9 (1.1)
Week 8	3.0 (1.7)	3.1 (1.1)
Week 12	3.3 (1.7)	2.9 (1.1)
Week 16	3.5 (1.7)	2.6 (1.1)

14. Secondary Outcome

Title	Aberrant Behavior Checklist (ABC) Subscale Score (Stereotypy)
Description	The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Stereotypy subscale assesses the participant's level of stereotypic behavior. This subscale comprises 7 items with scores ranging from 0 to 3 for a total range of scores from 0 to 21. A higher score represents a greater level of stereotypic behavior. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	1.3 (3.2)	2.2 (2.0)
Week 4	1.1 (3.2)	2.4 (2.0)
Week 8	1.0 (3.2)	2.5 (2.0)
Week 12	1.3 (3.2)	2.2 (2.0)
Week 16	1.6 (3.2)	1.6 (2.0)

15. Secondary Outcome

Title	Aberrant Behavior Checklist (ABC) Subscale Score (Irritability)
Description	The Aberrant Behavior Checklist (ABC) is a 58-item caregiver questionnaire developed to assess medication effects in individuals with developmental disorders and includes 5 distinct subscales of behavioral symptoms. The ABC-Irritability subscale assesses the participant's level of irritability. This subscale comprises 15 items with scores ranging from 0 to 3 for a total range of scores from 0 to 45. A higher score represents a greater level of irritability. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	9.6 (5.1)	8.3 (3.2)
Week 4	9.4 (5.1)	8.6 (3.2)
Week 8	9.7 (5.1)	8.3 (3.2)
Week 12	9.7 (5.1)	8.3 (3.2)
Week 16	9.8 (5.1)	8.1 (3.2)

16. Secondary Outcome

Title	Clinical Global Impression-Severity (CGI-S) Score
Description	The CGI-Severity (CGI-S) scale is a 7-point, clinician-rated scale providing an overall assessment of patient functioning relative to other patients with a similar diagnosis (1=not at all ill to 7=severely ill). A higher score indicates a higher level of severity of psychopathology. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	4.74 (0.6)	4.56 (0.3)
Week 4	4.70 (0.6)	4.60 (0.3)
Week 8	4.71 (0.6)	4.58 (0.3)
Week 12	4.72 (0.6)	4.58 (0.3)
Week 16	4.70 (0.6)	4.60 (0.3)

17. Secondary Outcome

Title	Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score of Much Improved or Very Much Improved
Description	The clinician-rated CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. The CGI-Improvement (CGI-I) scale rates overall improvement or worsening of illness (ie, ASD) relative to baseline. Possible scores on this scale range from 1-6 with the following assigned values: 1 = "Very Much Improved"; 2 = "Much Improved; 3 = "Minimally improved"; 4 = "No change"; 5 = "Minimally worse"; 6= "Much worse." A higher score indicates worsening of illness (ie, ASD), whereas a lower score indicates improvement of illness. This scale was measured at Week 4, Week 8, Week 12, and Week 16. In this measure, the number of participants in each treatment arm determined by the study physician to be "Much Improved" or "Very Much Improved" (indicative of meaningful clinical improvement) were counted.
Time Frame	Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Very Much Improved or Much Improved	3 12.5%	1 4.2%
No Improvement to Very Much Worse	21 87.5%	23 95.8%
Very Much Improved or Much Improved	4 16.7%	2 8.3%
No Improvement to Very Much Worse	20 83.3%	22 91.7%
Very Much Improved or Much Improved	3 12.5%	4 16.7%
No Improvement to Very Much Worse	21 87.5%	20 83.3%
Very Much Improved or Much Improved	0 0%	1 4.2%
No Improvement to Very Much Worse	24 100%	23 95.8%

18. Secondary Outcome

Title	Repetitive Behavior Scale-Revised (RBSR) Total Score
Description	The RBS-R is a 43-item, informant-based questionnaire designed to quantify a range of restricted, repetitive behaviors (RRB) observed in ASD. Scores for each item range from 0 = "Behavior does not occur" to 3 = "Behavior occurs and is a severe problem". Thus the total range is 0 to 129. A higher score indicates a higher breadth of repetitive behaviors. This scale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	23.0 (14.0)	22.3 (8.7)
Week 4	21.7 (14.0)	23.5 (8.7)
Week 8	23.3 (14.0)	22.0 (8.7)
Week 12	23.3 (14.0)	22.0 (8.7)
Week 16	24.2 (14.0)	21.0 (8.7)

19. Secondary Outcome

Title	Mean Red Blood Cell Value
Description	This measure assesses the red blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	5.0 (0.3)	5.1 (0.3)
Week 12	5.1 (0.3)	5.0 (0.3)

20. Secondary Outcome

Title	Mean White Blood Cell Value
Description	This measure assesses the white blood cell value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	6.3 (2.3)	6.5 (2.2)
Week 12	6.0 (1.8)	6.9 (2.2)

21. Secondary Outcome

Title	Mean Hemoglobin Value
Description	This measure assesses the hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	14.8 (1.4)	15.0 (1.1)
Week 12	15.0 (1.2)	14.5 (1.0)

22. Secondary Outcome

Title	Mean Hematocrit Value
Description	This measure assesses the hematocrit value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	43.8 (3.5)	44.4 (2.9)
Week 12	44.4 (3.0)	43.2 (2.8)

23. Secondary Outcome

Title	Mean Corpuscular Volume Value
Description	This measure assesses the mean corpuscular volume value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	87.3 (3.2)	86.8 (4.6)
Week 12	87.8 (3.1)	86.6 (3.8)

24. Secondary Outcome

Title	Mean Corpuscular Hemoglobin Value
Description	This measure assesses the mean corpuscular hemoglobin value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	29.4 (1.7)	29.3 (1.8)
Week 12	29.7 (1.2)	29.2 (1.8)

25. Secondary Outcome

Title	Mean Corpuscular Hemoglobin Concentration Value
Description	This measure assesses the mean corpuscular hemoglobin concentration value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	33.8 (1.0)	33.9 (1.1)
Week 12	33.8 (0.9)	33.7 (0.9)

26. Secondary Outcome

Title	Mean Red Blood Cell Distribution Width Value
Description	This measure assesses the red blood cell distribution width value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	13.6 (0.8)	13.7 (1.0)
Week 12	13.6 (0.9)	13.6 (1.0)

27. Secondary Outcome

Title	Mean Platelets Value
Description	This measure assesses the platelets value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	253.8 (74.7)	286.0 (67.5)
Week 12	246.0 (69.5)	279.3 (57.7)

28. Secondary Outcome

Title	Mean Absolute Neutrophils Value
Description	This measure assesses the absolute neutrophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	3.5 (2.0)	3.7 (1.8)
Week 12	3.3 (1.5)	6.3 (11.0)

29. Secondary Outcome

Title	Mean Absolute Lymphocytes Value
Description	This measure assesses the absolute lymphocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	2.1 (0.6)	2.1 (0.5)
Week 12	1.9 (0.6)	3.5 (6.9)

30. Secondary Outcome

Title	Mean Absolute Monocytes Value
Description	This measure assesses the absolute monocytes value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	0.5 (0.2)	0.6 (0.2)
Week 12	0.5 (0.1)	0.9 (1.6)

31. Secondary Outcome

Title	Mean Absolute Eosinophils Value
Description	This measure assesses the absolute eosinophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	0.2 (0.1)	0.1 (0.1)
Week 12	0.2 (0.1)	0.2 (0.2)

32. Secondary Outcome

Title	Mean Absolute Basophils Value
Description	This measure assesses the absolute basophils value as part of the complete blood count measurement. This blood count measure was assessed at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	0.013 (0.034)	0.013 (0.034)
Week 12	0.004 (0.021)	0.009 (0.029)

33. Secondary Outcome

Title	Mean Serum Chemistries (Sodium)
Description	This measure assesses the change in the patient's sodium levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	140.6 (2.3)	141.0 (2.0)
Week 12	141.8 (2.5)	141.3 (1.8)

34. Secondary Outcome

Title	Mean Serum Chemistries (Potassium)
Description	This measure assesses the change in the patient's potassium levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	4.4 (0.4)	4.5 (0.4)
Week 12	4.7 (0.6)	4.5 (0.4)

35. Secondary Outcome

Title	Mean Serum Chemistries (Chloride)
Description	This measure assesses the change in the patient's chloride levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	100.1 (2.1)	99.6 (1.9)
Week 12	100.1 (2.3)	100.7 (2.1)

36. Secondary Outcome

Title	Mean Serum Chemistries (Bicarbonate)
Description	This measure assesses the change in the patient's bicarbonate levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	22.8 (3.0)	22.3 (1.5)
Week 12	23.1 (2.7)	22.8 (2.4)

37. Secondary Outcome

Title	Mean Serum Chemistries (Blood Urea Nitrogen)
Description	This measure assesses the change in the patient's blood urea nitrogen levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	13.0 (4.8)	11.4 (2.8)
Week 12	13.3 (4.3)	11.6 (3.5)

38. Secondary Outcome

Title	Mean Serum Chemistries (Creatinine)
Description	This measure assesses the change in the patient's creatinine levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	0.8 (0.1)	0.8 (0.2)
Week 12	0.8 (0.1)	0.8 (0.2)

39. Secondary Outcome

Title	Mean Serum Chemistries (Glucose)
Description	This measure assesses the change in the patient's glucose levels. This serum chemistry level was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	90.9 (13.0)	91.1 (12.6)
Week 12	87.0 (18.3)	86.3 (13.5)

40. Secondary Outcome

Title	Mean Liver Function Tests Values (Alanine Transaminase)
Description	This measure assesses the change in the patient's level of liver function through measure of alanine transaminase (ALT). This liver function test value was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	22.1 (16.7)	26.0 (18.0)
Week 12	29.6 (40.7)	20.7 (10.8)

41. Secondary Outcome

Title	Mean Liver Function Tests Values (Aspartate Transaminase)
Description	This measure assesses the change in the patient's level of liver function through measure of aspartate transaminase. This liver function test value was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	22.3 (10.2)	21.9 (5.8)
Week 12	25.2 (10.6)	19.8 (5.1)

42. Secondary Outcome

Title	Mean Liver Function Tests Values (Total Bilirubin)
Description	This measure assesses the change in the patient's level of liver function through measure of total bilirubin. This liver function test value was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	0.5 (0.3)	0.4 (0.3)
Week 12	0.5 (0.2)	0.5 (0.4)

43. Secondary Outcome

Title	Mean Value of Thyroid Stimulating Hormone (TSH)
Description	This measure assesses the change in the patient's value of thyroid stimulating hormone. This hormone value was measured at Baseline and Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	2.3 (1.2)	2.2 (1.2)
Week 12	2.3 (1.2)	1.8 (1.1)

44. Secondary Outcome

Title	Least Squares Mean of Vital Signs (Weight)
Description	This measure assesses the change in the patient's weight (lbs). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	147.1 (28.1)	148.3 (17.4)
Week 4	147.2 (28.1)	148.2 (17.4)
Week 8	146.8 (28.1)	148.6 (17.4)
Week 12	146.9 (28.1)	148.6 (17.4)
Week 16	146.8 (28.1)	148.6 (17.4)

45. Secondary Outcome

Title	Least Squares Mean of Vital Signs (Height)
Description	This measure assesses the change in the patient's height (centimeters). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	173.9 (6.5)	173.3 (4.0)
Week 4	173.9 (6.5)	173.3 (4.0)
Week 8	173.9 (6.5)	173.3 (4.0)
Week 12	173.9 (6.5)	173.3 (4.0)
Week 16	173.9 (6.5)	173.3 (4.0)

46. Secondary Outcome

Title	Least Squares Mean of Vital Signs (Blood Pressure)
Description	This measure assesses the change in the patient's systolic and diastolic blood pressure. This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline Systolic	115.2 (6.6)	116.7 (4.1)
Baseline Diastolic	69.8 (4.5)	70.6 (2.8)
Week 4 Systolic	116.3 (6.6)	115.5 (4.1)
Week 4 Diastolic	69.7 (4.5)	70.7 (2.8)
Week 8 Systolic	116.4 (6.6)	115.4 (4.1)
Week 8 Diastolic	69.6 (4.5)	70.8 (2.8)
Week 12 Systolic	116.2 (6.6)	115.7 (4.1)
Week 12 Diastolic	71.0 (4.5)	69.4 (2.8)
Week 16 Systolic	116.2 (6.6)	115.7 (4.1)
Week 16 Diastolic	71.1 (4.5)	69.3 (2.8)

47. Secondary Outcome

Title	Least Squares Mean of Vital Signs (Heart Rate)
Description	This measure assesses the change in the patient's heart rate (beats per minute). This vital sign was measured at Baseline, Week 4, Week 8, Week 12, and Week 16.
Time Frame	Baseline, Week 4, Week 8, Week 12, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulforaphane	Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb	Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
Measure Participants	24	24
Baseline	86.1 (8.6)	87.5 (5.4)
Week 4	88.0 (8.6)	85.6 (5.4)
Week 8	87.8 (8.6)	85.7 (5.4)
Week 12	86.5 (8.6)	87.0 (5.4)
Week 16	90.0 (8.6)	83.5 (5.4)

Adverse Events

Time Frame	Adverse events were assessed from baseline to week 16 (a total of 16 weeks).
Adverse Event Reporting Description	Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Arm/Group Title	Sulforaphane		Placebo
Arm/Group Description	Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if <100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb		Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm.
All Cause Mortality
	Sulforaphane		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Sulforaphane		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Sulforaphane		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/24 (58.3%)		14/24 (58.3%)
Gastrointestinal disorders
Appetite Decrease	0/24 (0%)		1/24 (4.2%)
Stomach Discomfort	1/24 (4.2%)		0/24 (0%)
General disorders
Fatigue	0/24 (0%)		1/24 (4.2%)
Nervous system disorders
Headache	1/24 (4.2%)		1/24 (4.2%)
Psychiatric disorders
Aggression	2/24 (8.3%)		2/24 (8.3%)
Anxiety	1/24 (4.2%)		0/24 (0%)
Difficulty Falling Asleep	1/24 (4.2%)		0/24 (0%)
Irritability	3/24 (12.5%)		4/24 (16.7%)
Restlessness	2/24 (8.3%)		1/24 (4.2%)
Sedation	0/24 (0%)		1/24 (4.2%)
Self-injurious Behavior	0/24 (0%)		2/24 (8.3%)
Stereotypy	1/24 (4.2%)		1/24 (4.2%)
Suicidal Ideation	1/24 (4.2%)		0/24 (0%)
Skin and subcutaneous tissue disorders
Localized Rash	1/24 (4.2%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.