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Trial record 56 of 76 for:    Long-chain fatty acids

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

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ClinicalTrials.gov Identifier: NCT01883817
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Robert McNamara, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. ADHD Symptoms [ Time Frame: 10 weeks ]
    Clinical improvement as measured by the ADHD Rating Scale


Secondary Outcome Measures :
  1. Cortical Functional Integrity [ Time Frame: 10 weeks ]
    Prefrontal cortical structural and functional connectivity measures



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883817


Locations
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United States, Ohio
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
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Principal Investigator: Robert K McNamara, PhD University of Cincinnati

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Responsible Party: Robert McNamara, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01883817     History of Changes
Other Study ID Numbers: 2013-0199
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert McNamara, University of Cincinnati:
ADHD

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders