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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
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
Unilever R&D

Tracking Information
First Submitted Date  ICMJE February 28, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
Cognitive control task - functional MRI [ Time Frame: change over 16 week intervention period (pre/post) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2012)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
Official Title  ICMJE The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder
  • Healthy
Intervention  ICMJE
  • Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
    650 mg EPA + 650 mg DHA daily
    Other Names:
    • EPA
    • DHA
  • 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:
    • Mono Unsaturated Fatty Acid
    • Poly Unsaturated Fatty Acid
  • Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
    650 mg EPA and 650 mg DHA daily
    Other Names:
    • EPA
    • DHA
  • 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
Study Arms  ICMJE
  • Active Comparator: ADHD active
    4 month intervention with EPA/DHA in ADHD group
    Intervention: Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
  • Placebo Comparator: ADHD Placebo
    4 month dietary intervention with placebo in ADHD group
    Intervention: Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group
  • Active Comparator: Active Healthy control
    4 month dietary intervention with DHA/EPA in healthy control group
    Intervention: Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid
  • Placebo Comparator: Healthy placebo
    4 month dietary intervention with placebo in healthy control group
    Intervention: Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2013)
79
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2012)
80
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554462
Other Study ID Numbers  ICMJE 08033V
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unilever R&D
Study Sponsor  ICMJE Unilever R&D
Collaborators  ICMJE UMC Utrecht
Investigators  ICMJE
Study Director: Marco Hoeksma, PhD Unilever Research Vlaardingen
Principal Investigator: Sarah Durston, PhD UMC Utrecht
PRS Account Unilever R&D
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP