Effect of Omega-3 Supplementation on Child Behavior Problems

NCT ID: NCT02016079

Last Updated: 2013-12-19

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

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Antisocial Aggressive Externalizing Behavior Problems Internalizing Behavior Problems

Keywords

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randomized controlled trial omega-3 nutrition behavior problems externalizing internalizing antisocial aggressive

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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Omega-3

a fruit drink containing omega-3

Group Type EXPERIMENTAL

omega-3

Intervention Type DIETARY_SUPPLEMENT

200 ml fruit drink containing omega-3

Fruit drink

the same fruit drink given in the experimental arm, but not containing omega-3

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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omega-3

200 ml fruit drink containing omega-3

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Smartfish

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joint Child Health Project, Mauritius

OTHER

Sponsor Role lead

Responsible Party

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Tashneem Moohamed

National Director, JCHP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tashneem Moohamed, BSc

Role: PRINCIPAL_INVESTIGATOR

Joint Child Health Project

Cyril Dalais, MSc

Role: PRINCIPAL_INVESTIGATOR

Action Research Program, Educational Priroity Areas, Mauritius

Locations

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Joint Child Health Project

Quatre Bornes, , Mauritius

Site Status

Countries

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Mauritius

References

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Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.

Reference Type DERIVED
PMID: 25146492 (View on PubMed)

Other Identifiers

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JCHP-N3

Identifier Type: OTHER

Identifier Source: secondary_id

JCHP-01

Identifier Type: -

Identifier Source: org_study_id