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

Attention Deficit Disorder Clinical Trial

Official title:

Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883817
• Other study ID #: 2013-0199
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

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