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

This study has been terminated.
(Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods)
Sponsor:
Collaborator:
Zone Laboratories, Inc.
Information provided by:
Children's Heart Center
ClinicalTrials.gov Identifier:
NCT00447291
First received: March 12, 2007
Last updated: January 26, 2011
Last verified: September 2006

March 12, 2007
January 26, 2011
December 2006
March 2010   (final data collection date for primary outcome measure)
To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To compare the effect of Omega 3 fish oil dietary supplementation versus placebo on biometric measurement, lipid profile, serum markers for inflammation and insulin resistance in overweight children and adolescents undergoing treatment with a low-glycemic load diet and exercise.
Not Provided
Complete list of historical versions of study NCT00447291 on ClinicalTrials.gov Archive Site
To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To compare the changes in weekly physical activity, biometrics measurements and body mass index between overweight children and adolescents receiving Omega 3 fish oil supplementation versus placeb
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Overweight
  • Obesity
  • Drug: Supplement: Omega-3 Fish Oil
  • Behavioral: Multi-Disciplinary Nutrition & Exercise program
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
July 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00447291
06.02.001
No
Gary A. Mayman/ Principal investigator, Children's Heart Center
Children's Heart Center
Zone Laboratories, Inc.
Principal Investigator: Gary A. Mayman, MD Children's Heart Center
Children's Heart Center
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP