CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Omega-3-acid ethyl esters +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00915902
NCT00915902Phase 3Completed

Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents

Babu Balagopal·interventional·Posted Jun 8, 2009·Updated Nov 8, 2022

In Brief

A Phase 3 clinical trial evaluating Omega-3-acid ethyl esters and Placebo for Hypertriglyceridemia. Completed, enrolled 42 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.1 years ago

Interventions

Omega-3-acid ethyl estersdrug

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

Placebodrug

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