SAMe Trial for Patients With Alcoholic Cirrhosis

Conditions

• Alcoholic Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Placebo — DRUG
  2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months
• SAMe 400 mg tablet — DRUG
  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

Study Details

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.

Key Dates

Start date

Oct 22, 2020

Status verified

Mar 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

196 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Placebo
  Alcoholic Cirrhosis on placebo
• 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
• No Intervention: Non-drinking Controls
  Non-drinking healthy controls

Primary Outcome Measure

SAMe supplement's effect on all-cause mortality [ Time Frame: Baseline to end of 24 months ]

Central Contacts

• Maggie Hesler, B.S
  (317) 988-4545
  [email protected]

Locations (2)

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