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Effect of Omega-3 Fatty Acid on Cortical Function in ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883817
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date October 10, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
ADHD Symptoms [ Time Frame: 10 weeks ]
Clinical improvement as measured by the ADHD Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Cortical Functional Integrity [ Time Frame: 10 weeks ]
Prefrontal cortical structural and functional connectivity measures
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 Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Official Title  ICMJE Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD
Brief Summary The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.
Detailed Description This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Disorder
Intervention  ICMJE
  • Drug: DHA Omega-3
    Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks
    Other Names:
    • Docosahexaenoic acid
    • Omega 3 Fatty Acids
  • Drug: Placebo
    corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
    Other Name: Inactive drug
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks
    Intervention: Drug: Placebo
  • Experimental: DHA Omega-3
    Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks
    Intervention: Drug: DHA Omega-3
Publications * Not Provided

*   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: June 20, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of written informed consent/assent
  • Ages 5-15 years old
  • Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

Exclusion Criteria:

  • Contraindication to an MRI scan (i.e., braces, claustrophobia)
  • A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)
  • Greater than 1 year outside appropriate age/grade level
  • A history of intolerance or hypersensitivity to omega-3 fatty acids
  • Currently taking omega-3 supplements
  • Not proficient in English language
  • Any history of a hematological disorder or concomitant use of anticoagulant medications
  • Personal history of an Axis I psychiatric disorder other than ADHD
  • Inability to swallow capsules
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883817
Other Study ID Numbers  ICMJE 2013-0199
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert McNamara, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Robert K McNamara, PhD University of Cincinnati
PRS Account University of Cincinnati
Verification Date October 2018

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