Clinical Trial: Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

Brief Summary: Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be a reduction in hepatic production of triglycerides. Also decreases the hepatic production of very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is two fold. It would help in the decrease production of triglycerides by the liver and have antioxidant properties decreasing the production of free radicals in the liver. In doing so, steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.

Detailed Summary:
Sponsor: Huntington Medical Research Institutes

Current Primary Outcome: To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ]

Original Secondary Outcome: Same as current

Information By: Huntington Medical Research Institutes

Dates:
Date Received: July 15, 2009
Date Started: September 2009
Date Completion: September 2012
Last Updated: June 9, 2010
Last Verified: June 2010