Effects of SAMe in Patients With Alcoholic Liver Disease

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.

Conditions

• Liver Disease, Alcoholic

Interventions

DRUG

S-adenosylmethionine

Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.

DRUG

Placebo

Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Abbott

  collaborator INDUSTRY

• Joint Clinical Research Center

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of California, Davis

  lead OTHER

Principal Investigators

• Charles H Halsted, MD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2009-06-30

Completion

2009-09-30

Countries

• United States

Study Locations