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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Supplement: Omega-3 Fish Oil

Intervention Type DRUG

Multi-Disciplinary Nutrition & Exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No