Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02016079
Other study ID # JCHP-01
Secondary ID JCHP-N3
Status Completed
Phase Phase 2/Phase 3
First received December 10, 2013
Last updated December 14, 2013
Start date March 2010
Est. completion date December 2011

Study information

Verified date December 2013
Source Joint Child Health Project, Mauritius
Contact n/a
Is FDA regulated No
Health authority Mauritius: Ministry of Health and Quality of Life
Study type Interventional

Clinical Trial Summary

The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Dietary Supplement:
omega-3
200 ml fruit drink containing omega-3

Locations

Country Name City State
Mauritius Joint Child Health Project Quatre Bornes

Sponsors (1)

Lead Sponsor Collaborator
Joint Child Health Project, Mauritius

Country where clinical trial is conducted

Mauritius, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Behavior Checklist The outcome measure assessed internalizing and externalizing behavior problems in children 6 months No
Primary Reactive-Proactive Aggression Questionnaire A self-report measure of reactive and proactive forms of aggressive behavior 6 months No
Primary Antisocial Personality Screening Device A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism 6 months No
Secondary WISC estimate of IQ 6 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02633111 - DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
Completed NCT04648553 - Task-Based Grounding Program Phase 1