Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents

Children's Heart Center

Status and phase

Terminated

Phase 3

Conditions

Overweight

Obesity

Treatments

Drug: Supplement: Omega-3 Fish Oil

Behavioral: Multi-Disciplinary Nutrition & Exercise program

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447291

06.02.001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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