Phase 3
N=91
Effects of SAMe in Patients With Alcoholic Liver Disease
Liver Disease, Alcoholic
Bottom Line
View on ClinicalTrials.gov: NCT00573313 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Changes in Serum AST Levels — -13.5; -56 Units per liter (U/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- S-adenosylmethionine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum AST Levels |
-13.5; -56 | — |
| SECONDARY Changes in Serum SAM |
54; 7 | 0.36 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- viral Hepatitis B or C
- hemochromatosis
- Wilson Disease
- sclerosing cholangitis
- primary biliary cirrhosis
- other chronic disease
- renal insufficiency
Data sourced from ClinicalTrials.gov (NCT00573313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.