Effect of Omega-3 Supplementation on Child Behavior Problems

Phase 3CompletedNCT02016079

Joint Child Health Project, Mauritius200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Antisocial Aggressive Externalizing Behavior Problems Internalizing Behavior Problems

Interventions

omega-3DIETARY_SUPPLEMENT

200 ml fruit drink containing omega-3

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Joint Child Health Project

Quatre Bornes, Mauritius

Outcomes

Primary Outcomes

Child Behavior Checklist

The outcome measure assessed internalizing and externalizing behavior problems in children

Time frame: 6 months

Reactive-Proactive Aggression Questionnaire

A self-report measure of reactive and proactive forms of aggressive behavior

Time frame: 6 months

Antisocial Personality Screening Device

A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism

Time frame: 6 months

Secondary Outcomes

WISC

estimate of IQ

Time frame: 6 months

Data from ClinicalTrials.gov

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