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

This study has been completed.
Sponsor:
Collaborator:
Israel Association of Pediatricians
Information provided by (Responsible Party):
gal dubnov raz, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00874536
First received: April 1, 2009
Last updated: July 29, 2013
Last verified: July 2013
  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 ADHD-related questionnaires and a computerized test. 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:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • ADHD symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    scores of DSM and Conners questionnaires


Secondary Outcome Measures:
  • Computerized test performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    performance in a computerized test of attention


Enrollment: 40
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (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 16 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Israel Association of Pediatricians
  More Information

No publications provided

Responsible Party: gal dubnov raz, Senior physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00874536     History of Changes
Other Study ID Numbers: GDR3-HMO-CTIL
Study First Received: April 1, 2009
Last Updated: July 29, 2013
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
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014