Effects of SAMe in Patients With Alcoholic Liver Disease
|ClinicalTrials.gov Identifier: NCT00573313|
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : June 10, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease, Alcoholic||Drug: S-adenosylmethionine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of SAMe in Patients With Alcoholic Liver Disease|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||September 2009|
Experimental: S-adenosylmethionine (SAMe)
Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks
Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
Placebo Comparator: Sugar pill
ALD subjects receiving Placebo three times daily for 24 weeks.
Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
- 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.
- Changes in Serum SAM [ Time Frame: September 2005- June 2009 ]We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573313
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Charles H Halsted, MD||University of California, Davis|