Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease (RCT SAMe)
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ClinicalTrials.gov Identifier: NCT00851981 |
Recruitment Status
:
Completed
First Posted
: February 26, 2009
Last Update Posted
: September 13, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholic Hepatitis | Other: Placebo Dietary Supplement: SAMe | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Oral S-Adenosylmethionine Administration on Abnormalities of Hepatic Methionine Metabolism and Disease Progression in Alcoholic Liver Disease. A Randomized, Double Blind, Placebo-controlled Trial |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Other: Placebo
TID
|
Active Comparator: SAMe |
Dietary Supplement: SAMe
300 mg TID
|
- Change in plasma homocysteine, hepatic GSH and SAMe levels and hepatic expression of TNF,MAT1A,MAT2A,MS,CBS and BHMT. [ Time Frame: 1 year ]
- Changes in routine liver pathology,c-myc expression and markers of apoptosis, stellate cell activation and hepatocyte proliferation. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be chronic alcohol users, defined by a history of ethanol consumption on average > 40g/day for women and 60g/day for men for at least 1 year before inclusion.
- The presumptive diagnosis for alcoholic hepatitis will be: recent binge drinking; compatible physical findings (one or more: jaundice, enlarged liver, hepatic bruit, abdominal pain, loss of appetite, nausea); and a compatible biochemical profile (moderate elevation of AST over ALT, elevated total serum bilirubin); or a liver-spleen colloid scan suggestive of reticulo-endothelial redistribution and hepatic arterialization.
- The diagnosis of alcoholic hepatitis must be confirmed on liver biopsy, showing typical features of acute sclerosing hyaline necrosis 70.
- The degree of portal fibrosis as determined on liver biopsy, graded according to the Knodell score-modified by Ishak 71 must be less than or equal to 5 out of a possible score of 6, 6 indicating cirrhosis.
- The alcoholic hepatitis must be "stable", i.e. not requiring treatment by either pentoxifylline 72 or prednisone, with a Maddrey Score 73 {(PTpatient - PTcontrol) x 4.6 + TBmg/dL} < 32.
- Patients must be willing to participate in the trial, remain abstinent to alcohol, and compliant to the treatment regimen, and undergo a post-treatment liver biopsy.
Exclusion Criteria:
- Patients who have either compensated cirrhosis (biopsy proven) or a clinical picture of severe cirrhosis defined as Child's class C and/or with a recent history (within one month) of decompensated liver disease (history of ascites, encephalopathy or variceal bleeding within one month of trial entry). These patients have reduced life expectancy below one year and are most often severely coagulopathic and cannot be biopsied.
- Patients who have severe acute alcoholic hepatitis of poor prognosis defined as a Maddrey Score > 32. These patients have a mortality rate of 50% during their hospitalization period when untreated by either prednisone or pentoxifylline.
- Patients who are receiving hepatotropic treatments such as colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, and pentoxifylline.
- Patients who are receiving known hepatotoxic long-term treatments such as NSAIDs, statins, neuroleptics, certain anti-convulsive medications, or high-dose acetaminophen.
- Patients suspected of having hepatocellular carcinoma.
- Patients who have contra-indications to liver biopsy.
- Patients who have a liver biopsy that does not yield sufficient specimen for analyses.
- Patients who have untreated deficiencies of folic acid, vitamin B6 or B12.
- Patients who have chronic active Hepatitis B or C, hemochromatosis, autoimmune hepatitis, or a cholangiopathy.
- Patients with psychotic disorders, and in particular manic depression (contra indication to SAMe treatment).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851981
United States, California | |
Loma Linda University | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Michel H Mendler, M.D. | Loma Linda Univeristy |
Responsible Party: | Michel H. Mendler, M.D. / PI, Loma Linda Univeristy |
ClinicalTrials.gov Identifier: | NCT00851981 History of Changes |
Other Study ID Numbers: |
55302 1R21AA014269-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | February 26, 2009 Key Record Dates |
Last Update Posted: | September 13, 2010 |
Last Verified: | September 2010 |
Keywords provided by Loma Linda University:
Alcohol Liver Disease |
Additional relevant MeSH terms:
Liver Diseases Hepatitis, Alcoholic Liver Diseases, Alcoholic Digestive System Diseases Hepatitis |
Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |