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

Phase 3

Completed

• Conditions: Attention Deficit Disorder
• Interventions: Drug: Placebo; Drug: DHA Omega-3

• Registration Number: NCT01883817
• Lead Sponsor: University of Cincinnati

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 Timeline

• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Study Start: 2013-09
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Results First Submitted: 2021-07-06
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Results First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks
DHA Omega-3	DHA Omega-3	Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks

Primary Outcome Measures

Name	Time	Method
Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)	10 weeks	Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms

Trial Locations

Locations (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience; 🇺🇸 Cincinnati, Ohio, United States