Trial | NCT00447291  Report issue

Title

Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
Evaluation of the Safety and Efficacy of Omega-3 Fish Oil Dietary Supplementation in Biometric Measurement, Lipid Profile, Serum Markers for Inflammation, and Insulin Resistance in Overweight Children and Adolescents

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    60
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 activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.
Study Started
Dec 31
2006
Primary Completion
Mar 31
2010
Study Completion
Jul 31
2010
Last Update
Jan 27
2011
Estimate

Drug Supplement: Omega-3 Fish Oil

Behavioral Multi-Disciplinary Nutrition & Exercise program

Criteria 

Inclusion Criteria:

Between 8-18 years old
BMI ≥95th percentile
Patient & parent/guardian consent to participate
Attendance of Risk Factor Reduction lifestyle modification program

Exclusion Criteria:

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
No Results Posted