Effects of SAMe in Patients With Alcoholic Liver Disease
Completed · Phase 3 · Has a placebo group
Conditions studied: Liver Disease, Alcoholic
In brief
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.
Key facts
- Study ID
- NCT00573313
- Run by
- University of California, Davis
- People needed
- 94
- Starts
- 2005-09-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2017-05-30
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria with the presence of clinical and laboratory features of established liver disease. Also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study medication or placebo and required clinic visits and blood sampling.
- a history of chronic alcoholism without evidence of liver disease;
- healthy subjects without history of alcoholism or presence of liver disease.
You may not qualify if…
- viral Hepatitis B or C
- hemochromatosis
- Wilson Disease
- sclerosing cholangitis
- primary biliary cirrhosis
- other chronic disease
- renal insufficiency
Where it is running
- University of California, Davis Medical Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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