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

NCT ID: NCT00874536

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALA

This group will receive the ALA supplement

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

3 grams of ALA-containing plant oil

Placebo

This group will receive the placebo supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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

3 grams of ALA-containing plant oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* ADHD diagnosis
* informed consent

Exclusion Criteria

* refusal of any testing
* any comorbidities
* any medication or supplement use
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Israel Association of Pediatricians

UNKNOWN

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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gal dubnov raz

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization

Jerusalem, Jerusalem, Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 37058600 (View on PubMed)

Other Identifiers

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GDR3-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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