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

NCT00447291 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-01-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Supplement: Omega-3 Fish Oil

BEHAVIORAL

Multi-Disciplinary Nutrition & Exercise program

Sponsors & Collaborators

  • Zone Laboratories, Inc.

    collaborator INDUSTRY
  • Children's Heart Center

    lead INDUSTRY

Principal Investigators

  • Gary A. Mayman, MD · Children's Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-03-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447291 on ClinicalTrials.gov