Status:
COMPLETED
Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
DSM Nutritional Products, Inc.
Conditions:
Attention Deficit Disorder
Eligibility:
All Genders
5-15 years
Phase:
PHASE3
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 functiona...
Eligibility Criteria
Inclusion
- Provision of written informed consent/assent
- Ages 5-15 years old
- Meets DSM-IV-TR criteria for ADHD as determined by the KSADS
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01883817
Start Date
September 1 2013
End Date
March 3 2017
Last Update
March 16 2022
Active Locations (1)
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1
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219