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Effect of Omega-3 Supplementation on Child Behavior Problems

Randomized Controlled Trial of Omega-3 on Child Behavior Problems

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02016079
Enrollment
200
Registered
2013-12-19
Start date
2010-03-31
Completion date
2011-12-31
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive, Antisocial, Externalizing Behavior Problems, Internalizing Behavior Problems

Keywords

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

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTomega-3

200 ml fruit drink containing omega-3

Sponsors

Joint Child Health Project, Mauritius
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Child Behavior Checklist6 monthsThe outcome measure assessed internalizing and externalizing behavior problems in children
Reactive-Proactive Aggression Questionnaire6 monthsA self-report measure of reactive and proactive forms of aggressive behavior
Antisocial Personality Screening Device6 monthsA measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism

Secondary

MeasureTime frameDescription
WISC6 monthsestimate of IQ

Countries

Mauritius

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026