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

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder, Healthy

Intervention / Treatment
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* Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
* Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group
* Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
* Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for subjects with ADHD 8-12 year old boys Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC) Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF) Ability to speak and comprehend Dutch. Used to daily consumption of margarine Inclusion criteria for controls 8-12 year old boys No DSM-IV (APA, 1994) diagnosis, according to DISC interview No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF) Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine Exclusion Criteria: mental retardation (IQ < 70) major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system presence of metal objects in or around the body (pacemaker, dental braces) history of or present neurological disorder 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ADHD active<br>4 month intervention with EPA/DHA in ADHD group | Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid<br>* 650 mg EPA + 650 mg DHA daily<br>* Other names: DHA;|
| Placebo Comparator: ADHD Placebo<br>4 month dietary intervention with placebo in ADHD group | Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group<br>* Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value<br>* Other names: Poly Unsaturated Fatty Acid;|
| Active Comparator: Active Healthy control<br>4 month dietary intervention with DHA/EPA in healthy control group | Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid<br>* 650 mg EPA and 650 mg DHA daily<br>* Other names: DHA;|
| Placebo Comparator: Healthy placebo<br>4 month dietary intervention with placebo in healthy control group | Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group<br>* Placebo contains MUFA in stead of PUFA, same energy value<br>* Other names: Mono Unsaturated Fatty Acids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive control task - functional MRI |  | change over 16 week intervention period (pre/post) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire |  | Change over 16 week intervention period (pre/post) | 
| Fatty acids status from cheek cells (swabs) |  | Change over 16 week intervention period (pre/post) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PUFA, Omega-3, Attention, Cognitive control, Healthy, EPA, Eicosapentaenoic acid, DHA, Docosahexaenoic acid, ADHD