Effect of Omega-3 Supplementation on Child Behavior Problems
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ClinicalTrials.gov Identifier: NCT02016079 |
Recruitment Status :
Completed
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Antisocial Aggressive Externalizing Behavior Problems Internalizing Behavior Problems | Dietary Supplement: omega-3 | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Omega-3
a fruit drink containing omega-3
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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
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- Child Behavior Checklist [ Time Frame: 6 months ]The outcome measure assessed internalizing and externalizing behavior problems in children
- Reactive-Proactive Aggression Questionnaire [ Time Frame: 6 months ]A self-report measure of reactive and proactive forms of aggressive behavior
- Antisocial Personality Screening Device [ Time Frame: 6 months ]A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism
- WISC [ Time Frame: 6 months ]estimate of IQ

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Ages Eligible for Study: | 8 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Mauritius | |
Joint Child Health Project | |
Quatre Bornes, Mauritius |
Principal Investigator: | Tashneem Moohamed, BSc | Joint Child Health Project | |
Principal Investigator: | Cyril Dalais, MSc | Action Research Program, Educational Priroity Areas, Mauritius |
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 |
randomized controlled trial omega-3 nutrition behavior problems |
externalizing internalizing antisocial aggressive |
Aggression Problem Behavior Behavioral Symptoms |