---
title: Effects of SAMe in Patients With Alcoholic Liver Disease
nct_id: NCT00573313
overall_status: COMPLETED
phase: PHASE3
sponsor: University of California, Davis
study_type: INTERVENTIONAL
primary_condition: Liver Disease, Alcoholic
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00573313.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00573313"
ct_last_update_post_date: 2017-05-30
last_seen_at: "2026-05-12T06:54:43.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of SAMe in Patients With Alcoholic Liver Disease

**NCT ID:** [NCT00573313](https://clinicaltrials.gov/study/NCT00573313)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 94
- **Lead Sponsor:** University of California, Davis
- **Collaborators:** National Institute on Alcohol Abuse and Alcoholism (NIAAA), Abbott, Joint Clinical Research Center, University of Colorado, Denver, University of California, Los Angeles
- **Conditions:** Liver Disease, Alcoholic
- **Start Date:** 2005-09
- **Completion Date:** 2009-09
- **CT.gov Last Update:** 2017-05-30

## Brief Summary

Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.

## Detailed Description

We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria

* ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria with the presence of clinical and laboratory features of established liver disease. Also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study medication or placebo and required clinic visits and blood sampling.
* a history of chronic alcoholism without evidence of liver disease;
* healthy subjects without history of alcoholism or presence of liver disease.

Exclusion Criteria:

* viral Hepatitis B or C
* hemochromatosis
* Wilson Disease
* sclerosing cholangitis
* primary biliary cirrhosis
* other chronic disease
* renal insufficiency
```

## Arms

- **S-adenosylmethionine (SAMe)** (EXPERIMENTAL) — Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks
- **Sugar pill** (PLACEBO_COMPARATOR) — ALD subjects receiving Placebo three times daily for 24 weeks.

## Interventions

- **S-adenosylmethionine** (DRUG) — Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
- **Placebo** (DRUG) — Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.

## Primary Outcomes

- **Changes in Serum AST Levels** _(time frame: Week 0 to week 24)_ — Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.

## Secondary Outcomes

- **Changes in Serum SAM** _(time frame: September 2005- June 2009)_

## Locations (1)

- University of California, Davis Medical Center, Sacramento, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of california, davis medical center|sacramento|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00573313.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00573313*  
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