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Completed

NCT Number: NCT01554462

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Healthy Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Utrecht University Medical Center; Child and adolescent psychiatry

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eicosapentaenoic acid / Docosahexaenoic acid

Dietary Supplement

650 mg EPA + 650 mg DHA daily

Other names: EPA, DHA

Placebo dietary intervention (MUFA) in ADHD group

Dietary Supplement

Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value

Other names: Mono Unsaturated Fatty Acid, Poly Unsaturated Fatty Acid

Placebo dietary intervention (MUFA) in healthy control group

Dietary Supplement

Placebo contains MUFA in stead of PUFA, same energy value

Other names: Mono Unsaturated Fatty Acids

Primary outcomes

  1. Cognitive control task - functional MRI

    Time frame: change over 16 week intervention period (pre/post)

Secondary outcomes

  1. Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire

    Time frame: Change over 16 week intervention period (pre/post)

  2. Fatty acids status from cheek cells (swabs)

    Time frame: Change over 16 week intervention period (pre/post)

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • UMC Utrecht

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2012
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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