Back to resultsEffect of Omega-3 Supplementation on Child Behavior Problems
Primary Purpose
Antisocial, Aggressive, Externalizing Behavior Problems
Status
Completed
Phase
Phase 2
Locations
Mauritius
Study Type
Interventional
Intervention
omega-3
Sponsored by
About this trial
This is an interventional treatment trial for Antisocial focused on measuring randomized controlled trial, omega-3, nutrition, behavior problems, externalizing, internalizing, antisocial, aggressive
Eligibility Criteria
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
Sites / Locations
- Joint Child Health Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega-3
Fruit drink
Arm Description
a fruit drink containing omega-3
the same fruit drink given in the experimental arm, but not containing omega-3
Outcomes
Primary Outcome Measures
Child Behavior Checklist
The outcome measure assessed internalizing and externalizing behavior problems in children
Reactive-Proactive Aggression Questionnaire
A self-report measure of reactive and proactive forms of aggressive behavior
Antisocial Personality Screening Device
A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
Secondary Outcome Measures
WISC
estimate of IQ
Full Information
NCT ID
NCT02016079
First Posted
December 10, 2013
Last Updated
December 14, 2013
Sponsor
Joint Child Health Project, Mauritius
1. Study Identification
Unique Protocol Identification Number
NCT02016079
Brief Title
Effect of Omega-3 Supplementation on Child Behavior Problems
Official Title
Randomized Controlled Trial of Omega-3 on Child Behavior Problems
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Joint Child Health Project, Mauritius
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial, Aggressive, Externalizing Behavior Problems, Internalizing Behavior Problems
Keywords
randomized controlled trial, omega-3, nutrition, behavior problems, externalizing, internalizing, antisocial, aggressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3
Arm Type
Experimental
Arm Description
a fruit drink containing omega-3
Arm Title
Fruit drink
Arm Type
Placebo Comparator
Arm Description
the same fruit drink given in the experimental arm, but not containing omega-3
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3
Other Intervention Name(s)
Smartfish
Intervention Description
200 ml fruit drink containing omega-3
Primary Outcome Measure Information:
Title
Child Behavior Checklist
Description
The outcome measure assessed internalizing and externalizing behavior problems in children
Time Frame
6 months
Title
Reactive-Proactive Aggression Questionnaire
Description
A self-report measure of reactive and proactive forms of aggressive behavior
Time Frame
6 months
Title
Antisocial Personality Screening Device
Description
A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
Time Frame
6 months
Secondary Outcome Measure Information:
Title
WISC
Description
estimate of IQ
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tashneem Moohamed, BSc
Organizational Affiliation
Joint Child Health Project
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cyril Dalais, MSc
Organizational Affiliation
Action Research Program, Educational Priroity Areas, Mauritius
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Child Health Project
City
Quatre Bornes
Country
Mauritius
12. IPD Sharing Statement
Citations:
PubMed Identifier
25146492
Citation
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.
Results Reference
derived
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Effect of Omega-3 Supplementation on Child Behavior Problems
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