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Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00874536
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : July 30, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.

Condition or disease Intervention/treatment
Attention Deficit Hyperactivity Disorder Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA) Dietary Supplement: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD
Study Start Date : April 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ALA
This group will receive the ALA supplement
Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA)
3 grams of ALA-containing plant oil
Placebo Comparator: Placebo
This group will receive the placebo supplement
Dietary Supplement: Placebo


Outcome Measures

Primary Outcome Measures :
  1. ADHD symptoms [ Time Frame: 8 weeks ]
    scores of DSM and Conners questionnaires


Secondary Outcome Measures :
  1. Computerized test performance [ Time Frame: 8 weeks ]
    performance in a computerized test of attention


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ADHD diagnosis
  • informed consent

Exclusion Criteria:

  • refusal of any testing
  • any comorbidities
  • any medication or supplement use
Contacts and Locations

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): NCT00874536


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Israel Association of Pediatricians
More Information

Responsible Party: gal dubnov raz, Senior physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00874536     History of Changes
Other Study ID Numbers: GDR3-HMO-CTIL
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by gal dubnov raz, Sheba Medical Center:
ADHD
methylphenidate
omega-3

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms