Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Recruitment status was Recruiting
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.
Non-Alcoholic Fatty Liver Disease
Drug: placebo control
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease|
- To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Lovaza
Single blind, active treatment arm Lovaza, is the only fish oil supplement approved by the FDA. The Lovaza treatment group will take 4g of Lovaza daily for a minimum of 48 weeks.
Approximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration.
Placebo Comparator: Placebo
Single blind, Placebo arm study drug will contain 994.0 mg of corn oil and 6mg of alpha tocopherol as an excipient in a soft gelatin capsule shell. Subjects will take 4g daily for a minimum of 48 weeks.
Drug: placebo control
Approximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration.
|Contact: Roberta A Fitzgerald, RNfirstname.lastname@example.org|
|United States, California|
|HMRI - Liver Center||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Roberta A Fitzgerald, RN 626-397-5825 email@example.com|
|Principal Investigator: Edward A Mena, MD|
|Sub-Investigator: Myron J Tong, PhD, MD.|
|Principal Investigator:||Edward A Mena, MD||Huntington Medical Research Institutes - Liver Center|
|Study Director:||Myron J Tong, PhD, MD.||Huntington Medical Research Institutes - Liver Center|