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

December 10, 2013 updated by: Unilever R&D

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Inclusion criteria for subjects with ADHD

  1. 8-12 year old boys
  2. Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
  3. Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
  4. Ability to speak and comprehend Dutch.
  5. Used to daily consumption of margarine

Inclusion criteria for controls

  1. 8-12 year old boys
  2. No DSM-IV (APA, 1994) diagnosis, according to DISC interview
  3. No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF)
  4. Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine

Exclusion Criteria:

  1. mental retardation (IQ < 70)
  2. major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
  3. presence of metal objects in or around the body (pacemaker, dental braces)
  4. history of or present neurological disorder
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • DHA
  • EPA
Dietary supplement: Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA and 650 mg DHA daily
Other Names:
  • DHA
  • EPA
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 + 650 mg DHA daily
Other Names:
  • DHA
  • EPA
Dietary supplement: Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA and 650 mg DHA daily
Other Names:
  • DHA
  • EPA
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 Names:
  • Mono Unsaturated Fatty Acids

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Change over 16 week intervention period (pre/post)
Fatty acids status from cheek cells (swabs)
Time Frame: Change over 16 week intervention period (pre/post)
Change over 16 week intervention period (pre/post)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Collaborators

UMC Utrecht

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08033V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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