Effect of Omega-3 Supplementation on Child Behavior Problems

December 14, 2013 updated by: Tashneem Moohamed, Joint Child Health Project, Mauritius

Randomized Controlled Trial of Omega-3 on Child Behavior Problems

The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mauritius
      • Quatre Bornes, Mauritius
        • Joint Child Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • child
  • age between 8 and 16 years
  • residing in the community

Exclusion Criteria:

  • fish allergy
  • diagnosed mental disorder
  • mental retardation
  • on medication that may modify lipid metabolism
  • extensive use of nutritional supplements within the previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3
a fruit drink containing omega-3
Dietary supplement: omega-3
200 ml fruit drink containing omega-3
Other Names:
  • Smartfish
Placebo Comparator: Fruit drink
the same fruit drink given in the experimental arm, but not containing omega-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Behavior Checklist
Time Frame: 6 months
The outcome measure assessed internalizing and externalizing behavior problems in children
6 months
Reactive-Proactive Aggression Questionnaire
Time Frame: 6 months
A self-report measure of reactive and proactive forms of aggressive behavior
6 months
Antisocial Personality Screening Device
Time Frame: 6 months
A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WISC
Time Frame: 6 months
estimate of IQ
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Child Health Project, Mauritius

Investigators

  • Principal Investigator: Tashneem Moohamed, BSc, Joint Child Health Project
  • Principal Investigator: Cyril Dalais, MSc, Action Research Program, Educational Priroity Areas, Mauritius

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 14, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 14, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCHP-01
  • JCHP-N3 (Other Identifier: JCHP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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