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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01883817
Other study ID # 2013-0199
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2013
Est. completion date March 3, 2017

Study information

Verified date February 2022
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 3, 2017
Est. primary completion date March 3, 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Placebo
corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)

Locations

Country Name City State
United States University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV) Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms 10 weeks
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