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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874536
• Other study ID #: GDR3-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: July 29, 2013
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2013
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• ADHD diagnosis

• informed consent

Exclusion Criteria:

• refusal of any testing

• any comorbidities

• any medication or supplement use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• omega-3 fatty acid alpha-linolenic acid (ALA)
3 grams of ALA-containing plant oil
• Placebo

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Israel Association of Pediatricians

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD symptoms	scores of DSM and Conners questionnaires	8 weeks	No
Secondary	Computerized test performance	performance in a computerized test of attention	8 weeks	No