Clinical Trial: Effects of SAMe in Patients With Alcoholic Liver Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of SAMe in Patients With Alcoholic Liver Disease
Brief Summary: Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.
Detailed Summary: We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.
Sponsor: University of California, Davis
Current Primary Outcome: Changes in Serum AST Levels [ Time Frame: Week 0 to week 24 ]
Original Primary Outcome:
- Liver Histology, Methionine Metabolism and Liver Enzymes [ Time Frame: Present - Feb 2009 ]
- Primary: Define efficacy of SAM in treatment of alcoholic liver disease. Secondary: Define effects of alcoholic liver disease on hepatic methionine metabolism [ Time Frame: 4 years ]
Current Secondary Outcome: Changes in Serum SAM [ Time Frame: September 2005- June 2009 ]
Original Secondary Outcome: Secondary: Define effects of alcoholic liver disease on hepatic methionine metabolism [ Time Frame: 4 years ]
Information By: University of California, Davis
Dates:
Date Received: December 12, 2007
Date Started: September 2005
Date Completion:
Last Updated: May 24, 2017
Last Verified: May 2017