MedTrace Logo

Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.

NCT03216057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-03-18

Study results available
· View outcomes & findings →

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.

Conditions

  • Hypertriglyceridemia
  • Pediatric Obesity

Interventions

DIETARY_SUPPLEMENT

Omega-3 fatty acid 3 grams per day

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-20
Primary Completion
2016-11-22
Completion
2016-11-22

More Related Trials

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 NCT03216057 on ClinicalTrials.gov