Effect of Omega-3 Supplementation on Child Behavior Problems

NCT02016079 | Completed Phase 2 DMC

• 2 other identifiers: JCHP-01JCHP-N3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antisocial; Aggressive; Externalizing Behavior Problems; Internalizing Behavior Problems

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Child Behavior Checklist

  The outcome measure assessed internalizing and externalizing behavior problems in children

  6 months

• Reactive-Proactive Aggression Questionnaire

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

  6 months

• Antisocial Personality Screening Device

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

  6 months

Secondary Outcomes (1)

• WISC

  6 months

Study Arms (2)

Omega-3

EXPERIMENTAL

a fruit drink containing omega-3

Dietary Supplement: omega-3

Fruit drink

PLACEBO COMPARATOR

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

Interventions

omega-3 DIETARY_SUPPLEMENT

200 ml fruit drink containing omega-3

Also known as: Smartfish

Omega-3

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child
• age between 8 and 16 years
• residing in the community

You may not qualify if:

• fish allergy
• diagnosed mental disorder
• mental retardation
• on medication that may modify lipid metabolism
• extensive use of nutritional supplements within the previous 3 months

Sponsors & Collaborators

• Joint Child Health Project, Mauritius: lead

Study Sites (1)

Joint Child Health Project

Quatre Bornes, Mauritius

Location

Related Publications (1)

• 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.

  PMID: 25146492 DERIVED

MeSH Terms

Conditions

Antisocial Personality Disorder; Aggression; Mental Disorders

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Personality Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Tashneem Moohamed, BSc

  Joint Child Health Project

  PRINCIPAL INVESTIGATOR

• Cyril Dalais, MSc

  Action Research Program, Educational Priroity Areas, Mauritius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Director, JCHP

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 19, 2013
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

MA (1)