The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD

Unilever

Status: Completed

Conditions: Healthy; Attention Deficit Hyperactivity Disorder

Treatments: Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group; Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid; Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01554462

08033V

Details and patient eligibility

About

Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.

Enrollment: 79 patients

Sex: Male

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for subjects with ADHD

1. 8-12 year old boys
2. Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
3. Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
4. Ability to speak and comprehend Dutch.
5. Used to daily consumption of margarine

Inclusion criteria for controls

1. 8-12 year old boys
2. No DSM-IV (APA, 1994) diagnosis, according to DISC interview
3. No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF)
4. Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine

Exclusion criteria

1. mental retardation (IQ < 70)
2. major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
3. presence of metal objects in or around the body (pacemaker, dental braces)
4. history of or present neurological disorder
5. regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish (= 1 serving per week) or participation in intervention studies or (school-) health programs in the four months prior to study participation.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 4 patient groups, including a placebo group

ADHD active

Active Comparator group

Description:

4 month intervention with EPA/DHA in ADHD group

Treatment:

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

ADHD Placebo

Placebo Comparator group

Description:

4 month dietary intervention with placebo in ADHD group

Treatment:

Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group

Active Healthy control

Active Comparator group

Description:

4 month dietary intervention with DHA/EPA in healthy control group

Treatment:

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

Healthy placebo

Placebo Comparator group

Description:

4 month dietary intervention with placebo in healthy control group

Treatment:

Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group