SAMe Trial for Alcoholic Cirrhosis
This study is testing if a supplement called SAMe (S-adenosylmethionine) can help people with alcoholic cirrhosis (severe scarring of the liver due to alcohol). Researchers want to see if taking SAMe 400 mg tablets, three times a day for 24 months, can improve liver function and reduce the risk of death compared to taking a placebo (an inactive pill). You might be able to join if you are between 18 and 70 years old, have alcoholic cirrhosis, and your liver disease is classified as Child Class A or B. The study aims to enroll 196 participants, but its current status is unclear.
- Study design
- This is a randomized, double-blinded, placebo-controlled study, meaning participants will be randomly assigned to receive either SAMe or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 196 participants.
- What's involved
- Participants will take either SAMe 400 mg tablets or placebo tablets, two in the morning and one in the evening, for 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure all-cause mortality from the beginning of the study to the end of 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SAMe Trial for Patients With Alcoholic Cirrhosis
At a glance
Conditions
NCT04250259
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Indiana University Hospital
Indianapolis, Indianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Suthat Liangpunsakul, MD · PRINCIPAL_INVESTIGATOR · Indiana University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- SAMe supplement's effect on all-cause mortalityBaseline 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.