Clinical trial NCT01554462: The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
Official title: The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Healthy
Keywords: Attention
Cognitive control
ADHD
Healthy
EPA
Eicosapentaenoic acid
DHA
Docosahexaenoic acid
PUFA
Omega-3
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: UMC Utrecht
First posted: 2012-03-15
Enrollment: 79
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Cognitive control task - functional MRI
timeFrame: change over 16 week intervention period (pre/post)
Secondary outcomes:
measure: Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire
timeFrame: Change over 16 week intervention period (pre/post)
measure: Fatty acids status from cheek cells (swabs)
timeFrame: Change over 16 week intervention period (pre/post)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Center; Child and adolescent psychiatry
Study officials:
affiliation: Unilever Research Vlaardingen
name: Marco Hoeksma, PhD
role: STUDY_DIRECTOR
affiliation: UMC Utrecht
name: Sarah Durston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.