CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Fish Oil Supplementation +1 moredrug
Likely dose
Fish Oil Supplementation 4gfrom 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/NCT01285362
NCT01285362N/ACompleted

Fish Oil for the Treatment of Nonalcoholic Fatty Liver Disease in Children

Columbia University·interventional·Posted Jan 28, 2011·Updated May 5, 2022

In Brief

A clinical study evaluating Fish Oil Supplementation and Placebo Supplementation for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage liver disease. Weight loss, particularly if gradual, may lead to improvement in liver histology. Unfortunately, few patients in the pediatric population are willing to follow these recommendations and achieve weight loss. Medical treatment directed specifically at the liver disease has only recently been investigated and approved in patients with NAFLD. The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators of pathways that participate in decreased production and break down of triglycerides and fatty acids in the liver. The investigators hypothesize that children with obesity related NAFLD will normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver disease.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2011
Enrollment StartMar 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.4 years ago

Interventions

Fish Oil Supplementationdrug

Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.

Placebo Supplementationdrug

Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.