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NCT00851981 · ClinicalTrials.gov registry record · Phase 2

Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease

A Phase 2 study, sponsored by Loma Linda University.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00851981 is a Phase 2 study that has completed, run by Loma Linda University. The registered enrollment target is 60 participants.

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The verdict

NCT00851981, a Phase 2 study, has completed, sponsored by Loma Linda University.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

Background: Alcoholic liver disease is one of the most important causes of chronic liver disease in this country. There is currently no treatment for chronic alcoholic liver disease other than abstinence. Hepatic methionine metabolism is abnormal in these patients and one of the consequences is depletion of S-adenosylmethionine (SAMe) levels, which can affect numerous important cellular processes. SAMe has been increasingly utilized for the treatment of liver diseases although the protective mechanisms remain unclear. A recent randomized double-blind trial using SAMe in patients with alcoholic liver disease and found improvement in 2-year survival in those with less advanced liver disease. However, important changes in methionine metabolism and histological changes were not included in the study. Aim: The goal of this study is to determine the effect of SAMe administration on key metabolic abnormalities of the methionine cycle and on the recovery from alcoholic liver disease.

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT SAMe

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2008-10
Est. Completion 2010-05
Phase Phase 2

Sponsor

Loma Linda University

237 total trials

What the Registry Record Tells You About NCT00851981

The ClinicalTrials.gov registry entry for NCT00851981 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00851981 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00851981 about?

NCT00851981 is a clinical study titled "Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease". Background: Alcoholic liver disease is one of the most important causes of chronic liver disease in this country. There is currently no treatment for chronic alcoholic liver disease other than abstinence. Hepatic methionine metabolism is abnormal in these patients and one of the consequences is depl...

What is the current status of trial NCT00851981?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-10. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00851981?

The interventions under investigation include: Placebo (OTHER), SAMe (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00851981?

This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.