DADA: The Effects of DHA on Attention Deficit and Hyperactivity Disorder

Sponsor

IRCCS Eugenio Medea (Other)

Overall Status

Completed

CT.gov ID

NCT01796262

Collaborator

DMF srl (Dietetic Metabolic Food) (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Dietary Supplement: docosahexaenoic acid Dietary Supplement: Wheat germ oil	Phase 3

Detailed Description

The primary objective of this study is to investigate the relative efficacy and tolerability of omega-3 fatty acid supplementation, more specifically docosahexaenoic acid (DHA), in reducing attention-deficit/hyperactivity disorder (ADHD) symptoms in children. The present study is going to determine whether DHA supplementation induces modifications in fatty acid blood level and to evaluate the correlation between this possible modification and behavioral, neuropsychological and functional indexes. The study is a randomised, placebo-controlled double-blind intervention trial providing within- and between-group comparisons over 6 months. At the start of the study, the patients will be randomized to active treatment with DHA in a dose of one capsules twice daily, corresponding to a daily dose of 500 mg DHA, or to placebo (identical capsules with fishy odor containing 500 mg wheat germ oil). A total of 50 patients will be included in the study which is conducted in the Child Psychiatry Unit of "E. Medea" Scientific Institute (in northern Italy). The study participants are recruited from among patients assessed and diagnosed at this clinic, aged 6 to 14 years, who met DSM-IV criteria for a diagnosis of ADHD of any subtype (see Eligibility Criteria for further details). The study will also recruit 20 typically developing children to provide a control group at the start of the research for comparison of fatty acid blood level and other outcome measures (healthy children will not be included in the supplementation phase).

Clinical assessment will be made were made at three visits at the site: at baseline (Visit 1), 4 months (Visit 2) and 6 months (Visit 3). At Visits 1-2-3, a blood sample will be taken for analysis of the blood fatty acid profile. At Visit 1, informed consent is signed, inclusion and exclusion criteria are assessed, and the investigators make a medical evaluation, including medical and psychiatric history, assessment of diagnosis and comorbidity through parent interview according to DSM-IV criteria (DAWBA). A number of other examinations and instruments will be used, including height and weight, pulse and blood pressure, a neuromotor examination and an assessment of the general level of functioning with clinical scales and questionnaires completed by parents (see Outcome Measure Section for more details); several neuropsychological tests and reading test will be performed by a developmental neuropsychologist. At Visits 1-2, changes in the concentration of oxygenated Hb and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task will be assessed in a subset of patients (10 children from each group) with functional Near-Infrared Spectroscopy. Visit 2 will included the same examinations and instruments as Visit 1, with the exception of the reading test; Visit 3 will included all the same measures as Visit 1, with the exception of the fNIRS. Parents will return every month at the clinic to assess the compliance (defined as taking the prescribed dosage on more than 70% of the days in the interval), to be interviewed about current medical symptoms and any adverse events or side effects, and to get the supplementation dosage for the following month.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Wheat germ oil Wheat germ oil 250 mg pearl b.i.d. for six months	Dietary Supplement: Wheat germ oil Wheat germ oil 250 mg pearl b.i.d. for six months Other Names: Wheat germ oil 250 mg pearl
Active Comparator: docosahexaenoic acid DHA Richoil 250 mg pearl (DMF srl): b.i.d. for six months	Dietary Supplement: docosahexaenoic acid Supplementation with DHA Richoil 250mg pearl b.i.d. for six months Other Names: DHA Richoil (DMF srl)

Arm

Intervention/Treatment

Placebo Comparator: Wheat germ oil

Wheat germ oil 250 mg pearl b.i.d. for six months

Dietary Supplement: Wheat germ oil

Wheat germ oil 250 mg pearl b.i.d. for six months

Other Names:

Wheat germ oil 250 mg pearl

Active Comparator: docosahexaenoic acid

DHA Richoil 250 mg pearl (DMF srl): b.i.d. for six months

Dietary Supplement: docosahexaenoic acid

Supplementation with DHA Richoil 250mg pearl b.i.d. for six months

Other Names:

DHA Richoil (DMF srl)

Outcome Measures

Primary Outcome Measures

Change in ADHD RS-IV total score [Baseline, month 4, and month 6]
ADHD rating scale IV Parent Version-Investigator completed

Secondary Outcome Measures

Change in CPRS-R [Baseline, month 4, and month 6]
Conners Parent Rating Scale Revised
Change in CGI-S [Baseline, month 4, and month 6]
Clinical Global Impression - Severity
Change in C-GAS [Baseline, month 4, and month 6]
Children Global Assessment Scale
Change in CHQ [Baseline, month 4, and month 6]
Child Health Questionnaire Total Score
Change SDQ Total Score [Baseline, month 4, and month 6]
Strenght and Difficulties Questionnaires

Other Outcome Measures

Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy) [Baseline and month 4]
Changes in the concentration of oxygenated Hb and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task
Change in Cognitive Measure (ANT) [Baseline, month 4, and month 6]
Amsterdam Neuropsychological Task
Change in Fatty Acid blood level [Baseline, month 4, and month 6]
Fatty Acid blood level

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of ADHD based on DSM-IV criteria and confirmed with Development and Well-Being Assessment (DAWBA) interview
Comorbid disorder accepted: mood disorder, anxiety disorder, oppositional defiant disorder, conduct disorder, learning disorder
Total IQ equal or above 85
Aged from 6 to 14 years

Exclusion Criteria:

Autism, Schizophrenia or othe psychiatric disorder not included in inclusion criteria
associated neurologic, genetic, infectious or metabolic disorder, or a seizure disorder
present or past use of any psychoactive drugs