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

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01883817
• Collaborator: DSM Nutritional Products, Inc. (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder	Drug: DHA Omega-3; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Mar 3, 2017
• Actual Study Completion Date: Mar 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks	Drug: Placebo; corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA); Other Names: Inactive drug
Experimental: DHA Omega-3 Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks	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; Other Names: Docosahexaenoic acid Omega 3 Fatty Acids

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

• University of Cincinnati
• DSM Nutritional Products, Inc.

Investigators

• Principal Investigator: Robert K McNamara, PhD, University of Cincinnati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2013

More Information

Publications

None provided.

• Responsible Party: Robert McNamara, Associate Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT01883817
• Other Study ID Numbers: 2013-0199
• First Posted: Jun 21, 2013
• Last Update Posted: Mar 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Robert McNamara, Associate Professor, University of Cincinnati: ADHD
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Arm/Group Title	Placebo	DHA Omega-3
Arm/Group Description	Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)	Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks 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
Period Title: Overall Study
STARTED	14	16
COMPLETED	10	9
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Placebo	DHA Omega-3	Total
Arm/Group Description	Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)	Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks 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 12 weeks	Total of all reporting groups
Overall Participants	14	16	30
Age (Count of Participants)
<=18 years	14 100%	16 100%	30 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	3 21.4%	4 25%	7 23.3%
Male	11 78.6%	12 75%	23 76.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 28.6%	5 31.3%	9 30%
White	7 50%	9 56.3%	16 53.3%
More than one race	3 21.4%	2 12.5%	5 16.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%	16 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of >40, and at least one biological parent with bipolar I disorder.

Arm/Group Title	Placebo	DHA Omega-3
Arm/Group Description	Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)	Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks 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 12 weeks
Measure Participants	14	16
Mean (Standard Error) [score on a scale]	47.1 (8.5)	46.1 (6.6)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Placebo		DHA Omega-3
Arm/Group Description	Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 12 weeks Placebo: corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)		Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 12 weeks 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 12 weeks
All Cause Mortality
	Placebo		DHA Omega-3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)
Serious Adverse Events
	Placebo		DHA Omega-3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		DHA Omega-3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.