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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
omega-3 fatty acid alpha-linolenic acid (ALA)
Placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, methylphenidate, omega-3

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ADHD diagnosis
  • informed consent

Exclusion Criteria:

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

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALA

Placebo

Arm Description

This group will receive the ALA supplement

This group will receive the placebo supplement

Outcomes

Primary Outcome Measures

ADHD symptoms
scores of DSM and Conners questionnaires

Secondary Outcome Measures

Computerized test performance
performance in a computerized test of attention

Full Information

First Posted
April 1, 2009
Last Updated
July 29, 2013
Sponsor
Hadassah Medical Organization
Collaborators
Israel Association of Pediatricians
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1. Study Identification

Unique Protocol Identification Number
NCT00874536
Brief Title
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)
Official Title
The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Israel Association of Pediatricians

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, methylphenidate, omega-3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALA
Arm Type
Experimental
Arm Description
This group will receive the ALA supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive the placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acid alpha-linolenic acid (ALA)
Intervention Description
3 grams of ALA-containing plant oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
ADHD symptoms
Description
scores of DSM and Conners questionnaires
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Computerized test performance
Description
performance in a computerized test of attention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD diagnosis informed consent Exclusion Criteria: refusal of any testing any comorbidities any medication or supplement use
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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

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