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NCT Number: NCT00573313

Effects of SAMe in Patients With Alcoholic Liver Disease

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.

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Key information

Conditions

Liver Disease, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

About this study

We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-adenosylmethionine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Changes in Serum AST Levels

    Time frame: Week 0 to week 24

    Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.

Secondary outcomes

  1. Changes in Serum SAM

    Time frame: September 2005- June 2009

    We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Abbott
  • Joint Clinical Research Center
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of California, Los Angeles
  • University of Colorado, Denver

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2007
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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