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

Primary Purpose

Attention Deficit Hyperactivity Disorder, Healthy

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Eicosapentaenoic acid / Docosahexaenoic acid

Placebo dietary intervention (MUFA) in ADHD group

Eicosapentaenoic acid / Docosahexaenoic acid

Placebo dietary intervention (MUFA) in healthy control group

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention, Cognitive control, ADHD, Healthy, EPA, Eicosapentaenoic acid, DHA, Docosahexaenoic acid, PUFA, Omega-3

Eligibility Criteria

8 Years - 12 Years (Child)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Utrecht University Medical Center; Child and adolescent psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

ADHD active

ADHD Placebo

Active Healthy control

Healthy placebo

Arm Description

4 month intervention with EPA/DHA in ADHD group

4 month dietary intervention with placebo in ADHD group

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

4 month dietary intervention with placebo in healthy control group

Outcomes

Primary Outcome Measures

Cognitive control task - functional MRI

Secondary Outcome Measures

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

Fatty acids status from cheek cells (swabs)

Full Information

NCT ID

NCT01554462

First Posted

February 28, 2012

Last Updated

December 10, 2013

Sponsor

Unilever R&D

Collaborators

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT01554462

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unilever R&D

Collaborators

UMC Utrecht

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder, Healthy

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADHD active

Arm Type

Active Comparator

Arm Description

4 month intervention with EPA/DHA in ADHD group

Arm Title

ADHD Placebo

Arm Type

Placebo Comparator

Arm Description

4 month dietary intervention with placebo in ADHD group

Arm Title

Active Healthy control

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy placebo

Arm Type

Placebo Comparator

Arm Description

4 month dietary intervention with placebo in healthy control group

Intervention Type

Dietary Supplement

Intervention Name(s)

Eicosapentaenoic acid / Docosahexaenoic acid

Other Intervention Name(s)

EPA, DHA

Intervention Description

650 mg EPA + 650 mg DHA daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo dietary intervention (MUFA) in ADHD group

Other Intervention Name(s)

Mono Unsaturated Fatty Acid, Poly Unsaturated Fatty Acid

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Eicosapentaenoic acid / Docosahexaenoic acid

Other Intervention Name(s)

EPA, DHA

Intervention Description

650 mg EPA and 650 mg DHA daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo dietary intervention (MUFA) in healthy control group

Other Intervention Name(s)

Mono Unsaturated Fatty Acids

Intervention Description

Placebo contains MUFA in stead of PUFA, same energy value

Primary Outcome Measure Information:

Title

Cognitive control task - functional MRI

Time Frame

change over 16 week intervention period (pre/post)

Secondary Outcome Measure Information:

Title

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)

Title

Fatty acids status from cheek cells (swabs)

Time Frame

Change over 16 week intervention period (pre/post)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Hoeksma, PhD

Organizational Affiliation

Unilever Research Vlaardingen

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sarah Durston, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

Utrecht University Medical Center; Child and adolescent psychiatry

City

Utrecht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

25790022

Citation

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.

Results Reference

derived

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

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