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Completed

NCT Number: NCT02016079

Effect of Omega-3 Supplementation on Child Behavior Problems

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

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Key information

Conditions

Antisocial Aberrant Motor Behavior in Dementia Aggression Aggressive Antisocial Personality Disorder Behavior Behavioral Symptoms Externalizing Behavior Problems Internalizing Behavior Problems Mental Disorders Personality Disorders Social Behavior

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Joint Child Health Project

Quatre Bornes, Mauritius

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

200 ml fruit drink containing omega-3

Other names: Smartfish

Primary outcomes

  1. Child Behavior Checklist

    Time frame: 6 months

    The outcome measure assessed internalizing and externalizing behavior problems in children

  2. Reactive-Proactive Aggression Questionnaire

    Time frame: 6 months

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

  3. Antisocial Personality Screening Device

    Time frame: 6 months

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

Secondary outcomes

  1. WISC

    Time frame: 6 months

    estimate of IQ

Sponsors and collaborators

Lead sponsor

Joint Child Health Project, Mauritius

Other

Registry information

Official study title

Randomized Controlled Trial of Omega-3 on Child Behavior Problems

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2013
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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