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

Primary Purpose

Attention Deficit Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

DHA Omega-3

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Disorder focused on measuring ADHD

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

DHA Omega-3

Arm Description

Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks

Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01883817

First Posted

June 6, 2013

Last Updated

February 21, 2022

Sponsor

University of Cincinnati

Collaborators

DSM Nutritional Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01883817

Brief Title

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

Official Title

Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 3, 2017 (Actual)

Study Completion Date

March 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

Collaborators

DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder

Keywords

ADHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks

Arm Title

DHA Omega-3

Arm Type

Experimental

Arm Description

Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks

Intervention Type

Drug

Intervention Name(s)

DHA Omega-3

Other Intervention Name(s)

Docosahexaenoic acid, Omega 3 Fatty Acids

Intervention Description

Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Inactive drug

Intervention Description

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

Primary Outcome Measure Information:

Title

Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)

Description

Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert K McNamara, PhD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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