- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447291
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
January 26, 2011 updated by: Children's Heart Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89109
- Children's Heart Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare effects between Omega 3 fish oil and placebo
Time Frame: 3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare effects between Omega 3 fish oil and placebo
Time Frame: 3 months
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary A. Mayman, MD, Children's Heart Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 12, 2007
First Submitted That Met QC Criteria
March 12, 2007
First Posted (Estimate)
March 14, 2007
Study Record Updates
Last Update Posted (Estimate)
January 27, 2011
Last Update Submitted That Met QC Criteria
January 26, 2011
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06.02.001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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