The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
NCT ID: NCT01554462
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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ADHD active
4 month intervention with EPA/DHA in ADHD group
Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA + 650 mg DHA daily
ADHD Placebo
4 month dietary intervention with placebo in ADHD group
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
Active Healthy control
4 month dietary intervention with DHA/EPA in healthy control group
Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA and 650 mg DHA daily
Healthy placebo
4 month dietary intervention with placebo in healthy control group
Placebo dietary intervention (MUFA) in healthy control group
Placebo contains MUFA in stead of PUFA, same energy value
Interventions
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Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA + 650 mg DHA daily
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
Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA and 650 mg DHA daily
Placebo dietary intervention (MUFA) in healthy control group
Placebo contains MUFA in stead of PUFA, same energy value
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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.
8 Years
12 Years
MALE
Yes
Sponsors
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UMC Utrecht
OTHER
Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Marco Hoeksma, PhD
Role: STUDY_DIRECTOR
Unilever Research Vlaardingen
Sarah Durston, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Utrecht University Medical Center; Child and adolescent psychiatry
Utrecht, , Netherlands
Countries
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References
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Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
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.
Other Identifiers
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08033V
Identifier Type: -
Identifier Source: org_study_id