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Omega-3 Supplementation and Attention-Deficit-Hyperactivity Disorder (ADHD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00874536
First received: April 1, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 both ADHD-related questionnairres and tests, and blood fatty acid composition. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • ADHD symptoms [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood omega-3 and omega-6 fatty acid levels [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874536

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

No publications provided

Responsible Party: Gal Dubnov-Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00874536     History of Changes
Other Study ID Numbers: GDR3-HMO-CTIL
Study First Received: April 1, 2009
Last Updated: April 1, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
ADHD
methylphenidate
omega-3

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

ClinicalTrials.gov processed this record on May 16, 2013