CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 enrolled
Drug / intervention
Omega-3 fatty acid 3 grams per day +1 moredietary
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/NCT03216057
NCT03216057N/ACompleted

Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity. A Randomized, Double Blind, Placebo-controlled Clinical Trial.

Hospital Infantil de Mexico Federico Gomez·interventional·Posted Jul 13, 2017·Updated Mar 18, 2025

In Brief

A clinical study evaluating Omega-3 fatty acid 3 grams per day and Placebo for Hypertriglyceridemia and Pediatric Obesity. Completed, enrolled 168 participants.

Detailed Summary

The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other half received placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2017
Enrollment StartMay 20, 2008
Primary CompletionNov 22, 2016
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 9.0 years ago

Interventions

Omega-3 fatty acid 3 grams per daydietary

Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.

Placebodietary

Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.