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Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease

NCT00851981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-09-13

No results posted yet for this study

Summary

Background: Alcoholic liver disease is one of the most important causes of chronic liver disease in this country. There is currently no treatment for chronic alcoholic liver disease other than abstinence. Hepatic methionine metabolism is abnormal in these patients and one of the consequences is depletion of S-adenosylmethionine (SAMe) levels, which can affect numerous important cellular processes. SAMe has been increasingly utilized for the treatment of liver diseases although the protective mechanisms remain unclear. A recent randomized double-blind trial using SAMe in patients with alcoholic liver disease and found improvement in 2-year survival in those with less advanced liver disease. However, important changes in methionine metabolism and histological changes were not included in the study. Aim: The goal of this study is to determine the effect of SAMe administration on key metabolic abnormalities of the methionine cycle and on the recovery from alcoholic liver disease.

Conditions

  • Alcoholic Hepatitis

Interventions

OTHER

Placebo

TID

DIETARY_SUPPLEMENT

SAMe

300 mg TID

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Michel H Mendler, M.D. · Loma Linda Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00851981 on ClinicalTrials.gov