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

NCT01554462 | Completed

• 1 other identifier: 08033V
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder; Healthy

Keywords

Attention; Cognitive control; ADHD; Healthy; EPA; Eicosapentaenoic acid; DHA; Docosahexaenoic acid; PUFA; Omega-3

Outcome Measures

Primary Outcomes (1)

• Cognitive control task - functional MRI

  change over 16 week intervention period (pre/post)

Secondary Outcomes (2)

• 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)

Study Arms (4)

ADHD active

ACTIVE COMPARATOR

4 month intervention with EPA/DHA in ADHD group

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

ADHD Placebo

PLACEBO COMPARATOR

4 month dietary intervention with placebo in ADHD group

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

Active Healthy control

ACTIVE COMPARATOR

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

Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid

Healthy placebo

PLACEBO COMPARATOR

4 month dietary intervention with placebo in healthy control group

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

Interventions

Eicosapentaenoic acid / Docosahexaenoic acid DIETARY_SUPPLEMENT

650 mg EPA + 650 mg DHA daily

Also known as: EPA, DHA

ADHD active

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

Also known as: Mono Unsaturated Fatty Acid, Poly Unsaturated Fatty Acid

ADHD Placebo

Placebo dietary intervention (MUFA) in healthy control group DIETARY_SUPPLEMENT

Placebo contains MUFA in stead of PUFA, same energy value

Also known as: Mono Unsaturated Fatty Acids

Healthy placebo

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• UMC Utrecht: collaborator

Study Sites (1)

Utrecht University Medical Center; Child and adolescent psychiatry

Utrecht, Netherlands

Location

Related Publications (2)

• Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

  PMID: 37058600 DERIVED

• Bos DJ, Oranje B, Veerhoek ES, Van Diepen RM, Weusten JM, Demmelmair H, Koletzko B, de Sain-van der Velden MG, Eilander A, Hoeksma M, Durston S. Reduced Symptoms of Inattention after Dietary Omega-3 Fatty Acid Supplementation in Boys with and without Attention Deficit/Hyperactivity Disorder. Neuropsychopharmacology. 2015 Sep;40(10):2298-306. doi: 10.1038/npp.2015.73. Epub 2015 Mar 19.

  PMID: 25790022 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids; Fatty Acids, Monounsaturated

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Marco Hoeksma, PhD

  Unilever Research Vlaardingen

  STUDY DIRECTOR

• Sarah Durston, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

NL (1)