Clinical Trial: Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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. We 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.

Detailed Summary:

Scientific Abstract:

Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Overweight is defined as a body mass index (BMI) above the 95%centile for age and gender. The recent estimates of obesity prevalence based on the National Health and Nutrition Examination Study (NHANES) 1999-2000 suggest that 15.3% to 15.5% of 6-19 year old children have a BMI above the 95% centile for age. Major consequences of obesity include insulin resistance, type 2 diabetes mellitus, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). NAFLD represents a spectrum of conditions characterized by macrovesicular hepatic steatosis. The liver pathology encompasses a range from isolated fatty liver to steatohepatitis, advanced fibrosis, cirrhosis and end-stage liver disease. Nonalcoholic steatohepatitis (NASH) may progress to cirrhosis even in children. 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. Pharmacological therapy directed specifically at the liver disease has only recently been investigated in patients with NAFLD. Most of these studies have been uncontrolled pilot studies, lasting one year or less and have produced equivocal results. Thus, there is currently no effective treatment for this disorder. The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Long-chain polyunsaturated n-3 FA (LCPUFA) are major regulators of molecular pathways altering many areas of cellular and organ function, metabolism and gene expression, and are active in reducing inflammation through the eicasanoid pathway. N-3 LCPUFA are well established negative regulators of hepatic lipogene
Sponsor: Columbia University

Current Primary Outcome: Prevalence of normalized liver enzyme levels [ Time Frame: Up to 12 months from entry into the study ]

Original Primary Outcome: 1. To evaluate whether young adults with obesity related NAFLD will normalize their elevated liver enzyme levels with supplements of fish oil (n-3 FA containing eicosapentanoic acid and decosahexaenoic acid). [ Time Frame: Up to 12 months from entry into the study ]

Current Secondary Outcome: Prevalence of insulin resistance attenuated [ Time Frame: Up to 12 months from entry into the study ]

Original Secondary Outcome: Attenuation of insulin resistance [ Time Frame: Up to 12 months from entry into the study ]

Information By: Columbia University

Dates:
Date Received: January 26, 2011
Date Started: March 2013
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015