SAMe Trial for Patients with Alcoholic Cirrhosis
- Registration Number
- NCT04250259
- Lead Sponsor
- Indiana University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 196
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Alcoholic Cirrhosis on placebo 1,200 mg SAMe 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
- Primary Outcome Measures
Name Time Method SAMe supplement's effect on all-cause mortality Baseline to end of 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.
- Secondary Outcome Measures
Name Time Method SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS) baseline to end of 24 months The function of intestinal permeability will be evaluated by testing serum lipopolysaccharides (LPS) in patients who receive SAMe compared to those who receive placebo. Lipopolysaccharides (LPS) are large molecules consisting of a lipid and a polysaccharide that are bacterial toxins.
SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA baseline to 24 months Cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of mitochondrial DNA in the blood of patients who receive SAMe compared to those who receive placebo.
SAMe supplement's effect on liver deuteriation baseline to 24 months determining Proportion of subjects undergoing liver transplantation in patients who receive SAMe compared to those who receive placebo
SAMe supplement's effect on liver developing cancer baseline to 24 months Proportion of subjects developing new onset hepatocellular carcinoma in patients who receive SAMe compared to those who receive placebo
SAMe supplement's effect on infections of the liver baseline to 24 months Proportion of subjects with infection/sepsis (other than SBP) in patients who receive SAMe compared to those who receive placebo
SAMe supplement's effect on other parts of the body baseline to 24 months capture safety-related endpoints by determining proportion of patients with nausea and emesis, proportion of subjects with unexplained diarrhea in patients receive SAMe compared to those who receive placebo.
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD14 baseline to 24 months The function of intestinal permeability will be evaluated by testing soluble(s) CD14 in patients who receive SAMe compared to those who receive placebo. sCD14 either appears after shedding of mCD14 (48 kDa) or is directly secreted from intracellular vesicles (56 kDa).
SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD163 baseline to 24 months The function of intestinal permeability will be evaluated by testing soluble(s) CD163 in patients who receive SAMe compared to those who receive placebo. CD163 is an endocytic receptor for haptoglobin-hemoglobin complexes and is expressed solely on macrophages and monocytes. As a result of ectodomain shedding, the extracellular portion of CD163 circulates in blood as a soluble protein (sCD163).
SAMe supplement's effects on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by cytochrome P450 2E1 levels baseline to 24 months Levels of cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of cytochrome P450 2E1 (CYP2E1) enriched microparticles in patients who receive SAMe compared to those who receive placebo.CYP2E1 is a member of the cytochrome P450 mixed-function oxidase system, which is involved in the metabolism of xenobiotics in the body.
Trial Locations
- Locations (2)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States