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
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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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ADHD active
4 month intervention with EPA/DHA in ADHD group
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Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
650 mg EPA + 650 mg DHA daily
Other Names:
|
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:
|
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:
|
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 |
- Cognitive control task - functional MRI [ Time Frame: change over 16 week intervention period (pre/post) ]
- 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) ]
- Fatty acids status from cheek cells (swabs) [ Time Frame: Change over 16 week intervention period (pre/post) ]

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Ages Eligible for Study: | 8 Years to 12 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

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
Netherlands | |
Utrecht University Medical Center; Child and adolescent psychiatry | |
Utrecht, Netherlands |
Study Director: | Marco Hoeksma, PhD | Unilever Research Vlaardingen | |
Principal Investigator: | Sarah Durston, PhD | UMC Utrecht |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Unilever R&D |
ClinicalTrials.gov Identifier: | NCT01554462 History of Changes |
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:
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |