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Fish Oil Study for High Triglyceride Levels in Children

NCT00915902 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-11-08

Study results available
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Summary

High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Omega-3-acid ethyl esters

Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks

DRUG

Placebo

Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Samuel Gidding, MD · Nemours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00915902 on ClinicalTrials.gov