Status:
TERMINATED
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
Lead Sponsor:
Children's Heart Center
Collaborating Sponsors:
Zone Laboratories, Inc.
Conditions:
Overweight
Obesity
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
Brief Summary
Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activ...
Eligibility Criteria
Inclusion
- Between 8-18 years old
- BMI ≥95th percentile
- Patient \& parent/guardian consent to participate
- Attendance of Risk Factor Reduction lifestyle modification program
Exclusion
- Major surgical Procedure within 1 year
- Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
- Mentally Challenged
- Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
- Diabetes
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00447291
Start Date
December 1 2006
End Date
July 1 2010
Last Update
January 27 2011
Active Locations (1)
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1
Children's Heart Center
Las Vegas, Nevada, United States, 89109