NCT00874536

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2.2 years

First QC Date

April 1, 2009

Last Update Submit

July 29, 2013

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDmethylphenidateomega-3

Outcome Measures

Primary Outcomes (1)

  • ADHD symptoms

    scores of DSM and Conners questionnaires

    8 weeks

Secondary Outcomes (1)

  • Computerized test performance

    8 weeks

Study Arms (2)

ALA

EXPERIMENTAL

This group will receive the ALA supplement

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

Placebo

PLACEBO COMPARATOR

This group will receive the placebo supplement

Dietary Supplement: Placebo

Interventions

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

3 grams of ALA-containing plant oil

ALA
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD diagnosis
  • informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

    PMID: 37058600DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

IL(1)