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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554462

Enrollment

Registered

2012-03-15

Start date

2009-01-31

Completion date

2013-01-31

Last updated

2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Healthy

Keywords

Attention, Cognitive control, ADHD, Healthy, EPA, Eicosapentaenoic acid, DHA, Docosahexaenoic acid, PUFA, Omega-3

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.

Interventions

DIETARY_SUPPLEMENTEicosapentaenoic acid / Docosahexaenoic acid

650 mg EPA + 650 mg DHA daily

DIETARY_SUPPLEMENTPlacebo dietary intervention (MUFA) in ADHD group

Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value

DIETARY_SUPPLEMENTPlacebo dietary intervention (MUFA) in healthy control group

Placebo contains MUFA in stead of PUFA, same energy value

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

8 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026