RecruitingPhase 2NCT04250259

SAMe Trial for Patients With Alcoholic Cirrhosis

A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis

Sponsor

Indiana University

Enrollment

196 participants

Start Date

Oct 22, 2020

Study Type

INTERVENTIONAL

Conditions

Alcoholic Cirrhosis

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called SAMe 400 mg tablet for people with alcoholic cirrhosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months

DRUGSAMe 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