Effects of SAMe in Patients With Alcoholic Liver Disease
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.
Liver Disease, Alcoholic
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of SAMe in Patients With Alcoholic Liver Disease|
- Changes in Serum AST Levels [ Time Frame: Week 0 to week 24 ] [ Designated as safety issue: No ]Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.
- Changes in Serum SAM [ Time Frame: September 2005- June 2009 ] [ Designated as safety issue: No ]We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.
|Study Start Date:||September 2005|
|Study Completion Date:||September 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: S-adenosylmethionine (SAMe)
Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks
Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
Placebo Comparator: Sugar pill
ALD subjects receiving Placebo three times daily for 24 weeks.
Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573313
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Charles H Halsted, MD||University of California, Davis|