The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD - Full Text View

Purpose

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.

Condition	Intervention
Attention Deficit Hyperactivity Disorder Healthy	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Icosapent Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Unilever R&D:

Primary Outcome Measures:

Cognitive control task - functional MRI [ Time Frame: change over 16 week intervention period (pre/post) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Fatty acids status from cheek cells (swabs) [ Time Frame: Change over 16 week intervention period (pre/post) ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ADHD active 4 month intervention with EPA/DHA in ADHD group	Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid 650 mg EPA + 650 mg DHA daily Other Names: EPA DHA
Placebo Comparator: ADHD Placebo 4 month dietary intervention with placebo in ADHD group	Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group 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
Active Comparator: Active Healthy control 4 month dietary intervention with DHA/EPA in healthy control group	Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid 650 mg EPA and 650 mg DHA daily Other Names: EPA DHA
Placebo Comparator: Healthy placebo 4 month dietary intervention with placebo in healthy control group	Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group Placebo contains MUFA in stead of PUFA, same energy value Other Name: Mono Unsaturated Fatty Acids

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554462

Locations

Netherlands
Utrecht University Medical Center; Child and adolescent psychiatry
Utrecht, Netherlands

Sponsors and Collaborators

Unilever R&D

UMC Utrecht

Investigators

Study Director:	Marco Hoeksma, PhD	Unilever Research Vlaardingen
Principal Investigator:	Sarah Durston, PhD	UMC Utrecht

More Information

No publications provided

Responsible Party:	Unilever R&D
ClinicalTrials.gov Identifier:	NCT01554462 History of Changes
Other Study ID Numbers:	08033V
Study First Received:	February 28, 2012
Last Updated:	November 30, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Unilever R&D:

Attention
Cognitive control
ADHD
Healthy
EPA

Eicosapentaenoic acid
DHA
Docosahexaenoic acid
PUFA
Omega-3

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013