ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Omega-3 Supplementation on Child Behavior Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02016079
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Tashneem Moohamed, Joint Child Health Project, Mauritius

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

Condition or disease Intervention/treatment Phase
Antisocial Aggressive Externalizing Behavior Problems Internalizing Behavior Problems Dietary Supplement: omega-3 Phase 2 Phase 3

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Omega-3 on Child Behavior Problems
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Omega-3
a fruit drink containing omega-3
 Dietary Supplement: omega-3
200 ml fruit drink containing omega-3
Other Name: Smartfish
Placebo Comparator: Fruit drink
the same fruit drink given in the experimental arm, but not containing omega-3


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. WISC [ Time Frame: 6 months ]
    estimate of IQ


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016079


Locations
Mauritius
Joint Child Health Project
Quatre Bornes, Mauritius
Sponsors and Collaborators
Joint Child Health Project, Mauritius
Investigators
Principal Investigator: Tashneem Moohamed, BSc Joint Child Health Project
Principal Investigator: Cyril Dalais, MSc Action Research Program, Educational Priroity Areas, Mauritius
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tashneem Moohamed, National Director, JCHP, Joint Child Health Project, Mauritius
ClinicalTrials.gov Identifier: NCT02016079     History of Changes
Other Study ID Numbers: JCHP-01
JCHP-N3 ( Other Identifier: JCHP )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Tashneem Moohamed, Joint Child Health Project, Mauritius:
randomized controlled trial
omega-3
nutrition
behavior problems
 externalizing
internalizing
antisocial
aggressive

Additional relevant MeSH terms:
Aggression
Problem Behavior
Behavioral Symptoms