|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02016079 |
|
Date of registration:
|
10/12/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Omega-3 Supplementation on Child Behavior Problems
|
|
Scientific title:
|
Randomized Controlled Trial of Omega-3 on Child Behavior Problems |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02016079 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Mauritius
| | | | | | | |
|
Contacts
|
|
Name:
|
Tashneem Moohamed, BSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Joint Child Health Project |
|
|
Name:
|
Cyril Dalais, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Action Research Program, Educational Priroity Areas, Mauritius |
| |
|
Key inclusion & exclusion 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
Age minimum:
8 Years
Age maximum:
16 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Externalizing Behavior Problems
|
|
Aggressive
|
|
Antisocial
|
|
Internalizing Behavior Problems
|
|
Intervention(s)
|
|
Dietary Supplement: omega-3
|
|
Primary Outcome(s)
|
|
Reactive-Proactive Aggression Questionnaire
[Time Frame: 6 months]
|
|
Child Behavior Checklist
[Time Frame: 6 months]
|
|
Antisocial Personality Screening Device
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
WISC
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
JCHP-01
|
|
JCHP-N3
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|