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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554462
• Other study ID #: 08033V
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: December 10, 2013
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 8 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Healthy
• Hyperkinesis

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Netherlands	Utrecht University Medical Center; Child and adolescent psychiatry	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive control task - functional MRI		change over 16 week intervention period (pre/post)	No
Secondary	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)	No
Secondary	Fatty acids status from cheek cells (swabs)		Change over 16 week intervention period (pre/post)	No