Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT02735473
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 63.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

Condition or Disease	Intervention/Treatment	Phase
Fetal Alcohol Spectrum Disorders	Drug: Choline bitartrate; Drug: Placebo	Phase 2

Detailed Description

This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Choline bitartrate Powdered drink mix containing choline bitartrate 19 mg. per kg.	Drug: Choline bitartrate
Placebo Comparator: Placebo Powdered drink mix containing matching placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Elicited Imitation memory task - Short delay memory measure: 6 months [Change from baseline to 6 months]

   Elicited Imitation memory paradigm - short delay memory measure at 6 months

2. Elicited Imitation memory task - Short delay memory measure: 9 months [Change from baseline to 9 months]

   Elicited Imitation memory paradigm - short delay memory measure at 9 months

Secondary Outcome Measures

1. Stanford-Binet Intelligence Scales: 9 months [Change from baseline to 9 months]

   Stanford-Binet Intelligence Scales at 9 months

2. Minnesota Executive Function Scale: 6 months [Change from baseline to 6 months]

   Minnesota Executive Function Scale - Early Childhood Version at 6 months

3. Minnesota Executive Function Scale: 9 months [Change from baseline to 9 months]

   Minnesota Executive Function Scale - Early Childhood Version at 9 months

4. NIH Toolbox Flanker Task: 6 months [Change from baseline to 6 months]

   NIH Toolbox Flanker Inhibitory and Control Task at 6 months

5. NIH Toolbox Flanker Task: 9 months [Change from baseline to 9 months]

   NIH Toolbox Flanker Inhibitory and Control Task at 9 months

6. Child Behavior Checklist: 6 months [Change from baseline to 6 months]

   Child Behavior Checklist - parent report instrument at 6 months

7. Child Behavior Checklist: 9 months [Change from baseline to 9 months]

   Child Behavior Checklist - parent report instrument at 9 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Ages 2 years to 5 years of age

2. Available parent or legal guardian capable of giving informed consent for participation.

3. Documented prenatal alcohol exposure (self-report, social service records, or adoption records).

4. Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).

Exclusion Criteria:

1. Known history of a neurological condition (ex. epilepsy, traumatic brain injury)

2. Known history of a medical condition known to affect brain function.

3. Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)

4. Known history of very low birthweight (<1500 grams)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Jeffrey R Wozniak, Ph.D., University of Minnesota

Study Documents (Full-Text)

• Informed Consent Form - Jan 10, 2020

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02735473
• Other Study ID Numbers: PSYCH-2016-23989; R01AA024123
• First Posted: Apr 12, 2016
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Fetal Alcohol Spectrum Disorders; Choline

Study Results

No Results Posted as of Sep 23, 2021