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

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01554462
First received: February 28, 2012
Last updated: December 10, 2013
Last verified: December 2013
  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: 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:


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 ]

Enrollment: 79
Study Start Date: January 2009
Study Completion Date: January 2013
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

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 10, 2013
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
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014