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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
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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
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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
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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
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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
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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
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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
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Mauritius
Joint Child Health Project
Quatre Bornes, Mauritius
Sponsors and Collaborators
Joint Child Health Project, Mauritius
Investigators
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Principal Investigator: Tashneem Moohamed, BSc Joint Child Health Project
Principal Investigator: Cyril Dalais, MSc Action Research Program, Educational Priroity Areas, Mauritius
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tashneem Moohamed, National Director, JCHP, Joint Child Health Project, Mauritius
ClinicalTrials.gov Identifier: NCT02016079    
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:
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Aggression
Problem Behavior
Behavioral Symptoms