Effects of SAMe in Patients With Alcoholic Liver Disease
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, Davis
Collaborators:
Abbott Joint Clinical Research Center National Institute on Alcohol Abuse and Alcoholism (NIAAA) University of California, Los Angeles University of Colorado, Denver