Effect of Omega-3 Supplementation on Child Behavior Problems

Aggressive Clinical Trial

Official title:

Randomized Controlled Trial of Omega-3 on Child Behavior Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016079
• Other study ID #: JCHP-01
• Secondary ID: JCHP-N3
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 10, 2013
• Last updated: December 14, 2013
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2013
• Source: Joint Child Health Project, Mauritius
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mauritius: Ministry of Health and Quality of Life
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Aggressive
• Antisocial
• Externalizing Behavior Problems
• Internalizing Behavior Problems
• Mental Disorders

Intervention

Dietary Supplement:
• omega-3
200 ml fruit drink containing omega-3

Locations

Country	Name	City	State
Mauritius	Joint Child Health Project	Quatre Bornes

Sponsors (1)

Lead Sponsor	Collaborator
Joint Child Health Project, Mauritius

Country where clinical trial is conducted

Mauritius, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Behavior Checklist	The outcome measure assessed internalizing and externalizing behavior problems in children	6 months	No
Primary	Reactive-Proactive Aggression Questionnaire	A self-report measure of reactive and proactive forms of aggressive behavior	6 months	No
Primary	Antisocial Personality Screening Device	A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism	6 months	No
Secondary	WISC	estimate of IQ	6 months	No