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CompletedNCT00874536Updated Jul 30, 2013

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

An interventional study of omega-3 fatty acid alpha-linolenic acid (ALA) and Placebo in Attention Deficit Hyperactivity Disorder, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2013-07-30.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ADHD
  • methylphenidate
  • omega-3
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ADHD diagnosis
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • refusal of any testing
  • any comorbidities
  • any medication or supplement use
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    ALA

    This group will receive the ALA supplement

    Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA)

  • Placebo comparator
    Placebo

    This group will receive the placebo supplement

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementomega-3 fatty acid alpha-linolenic acid (ALA)

    3 grams of ALA-containing plant oil

  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. ADHD symptoms

    scores of DSM and Conners questionnaires

    Time frame: 8 weeks

Secondary outcomes

  1. Computerized test performance

    performance in a computerized test of attention

    Time frame: 8 weeks

07

Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00874536
Lead sponsor
Hadassah Medical Organization
Collaborators
Israel Association of Pediatricians
Responsible party
gal dubnov raz (Senior physician, Sheba Medical Center) — Principal investigator
First posted
Apr 2, 2009
Start date
Apr 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jul 30, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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