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

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ClinicalTrials.gov Identifier: NCT01554462
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
Unilever R&D

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : January 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive control task - functional MRI [ Time Frame: change over 16 week intervention period (pre/post) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Fatty acids status from cheek cells (swabs) [ Time Frame: Change over 16 week intervention period (pre/post) ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554462


Locations
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Netherlands
Utrecht University Medical Center; Child and adolescent psychiatry
Utrecht, Netherlands
Sponsors and Collaborators
Unilever R&D
UMC Utrecht
Investigators
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Study Director: Marco Hoeksma, PhD Unilever Research Vlaardingen
Principal Investigator: Sarah Durston, PhD UMC Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01554462    
Other Study ID Numbers: 08033V
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Keywords provided by Unilever R&D:
Attention
Cognitive control
ADHD
Healthy
EPA
 Eicosapentaenoic acid
DHA
Docosahexaenoic acid
PUFA
Omega-3
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms