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OpenTrials
Completed

NCT Number: NCT00874536

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD diagnosis
  • informed consent

Exclusion criteria

  • refusal of any testing
  • any comorbidities
  • any medication or supplement use

Treatment and study plan

omega-3 fatty acid alpha-linolenic acid (ALA)

Dietary Supplement

3 grams of ALA-containing plant oil

Placebo

Dietary Supplement

Primary outcomes

  1. ADHD symptoms

    Time frame: 8 weeks

    scores of DSM and Conners questionnaires

Secondary outcomes

  1. Computerized test performance

    Time frame: 8 weeks

    performance in a computerized test of attention

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Israel Association of Pediatricians

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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