SAMe Trial for Patients With Alcoholic Cirrhosis
Study Details
Study Description
Brief Summary
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Alcoholic Cirrhosis on placebo |
Dietary Supplement: Placebo
2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months
|
| Experimental: 1,200 mg SAMe SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months |
Dietary Supplement: SAMe 400 mg tablet
SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
|
| No Intervention: Non-drinking Controls Non-drinking healthy controls |
Outcome Measures
Primary Outcome Measures
- Measure the mortality of patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo [Baseline to 24 months]
The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Eligibility Criteria
Criteria
Inclusion criteria for patients with alcoholic cirrhosis
-
Patients must have had alcohol consumption averaging at least 80 grams per day (for men) or 50 grams per day (for women), for at least 10 years. These criteria are based on epidemiological evidence of the alcohol-cirrhosis relationship. The cutoff was set at a relatively high level so as to minimize the chance that cirrhosis was caused by factors other than alcohol
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Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
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subjects with clinical presentation either in Child Class A or B at the time of enrollment
Inclusion criteria for healthy control :
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individuals 18 to 70 years old
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able to provide informed consent
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subjects do not consume any alcohol or those who drink < 50 grams per day on average in women and < 80 grams per day on average in men and do not consume any alcohol within 3 months before the study and
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subjects are healthy without underlying acute or chronic medical conditions.
Exclusion criteria for patients with alcoholic cirrhosis
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Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
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Serum creatinine >1.5 mg/dl
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Known co-existing infection with hepatitis C, hepatitis B, or HIV
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Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
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Gastrointestinal bleeding within the prior 28 days3
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Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
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Women who are pregnant, may become pregnant, or nursing
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Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
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Subjects with history of/diagnosis of hepatocellular carcinoma
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Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
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Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
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Systemic antibiotic use or use of rifaximin for 10 days or more in last 2 months before the enrollment.
Exclusion criteria for all healthy control participants:
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individuals under the age of 18 or over the age of 70
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not able to provide informed consent
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subjects who consume any alcohol or those who drink > 50 grams per day on average in women and > 80 grams per day on average in men and consume any alcohol within 3 months before the study and
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subjects that are unhealthy with underlying acute or chronic medical conditions.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Suthat Liangpunsakul, MD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAMe Trial