Effects of SAMe in Patients With Alcoholic Liver Disease
3 other identifiers
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 12, 2007
CompletedFirst Posted
Study publicly available on registry
December 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
June 10, 2013
CompletedMay 30, 2017
May 1, 2017
3.8 years
December 12, 2007
February 6, 2013
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Serum AST Levels
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.
Week 0 to week 24
Secondary Outcomes (1)
Changes in Serum SAM
September 2005- June 2009
Study Arms (2)
S-adenosylmethionine (SAMe)
EXPERIMENTALAlcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks
Sugar pill
PLACEBO COMPARATORALD subjects receiving Placebo three times daily for 24 weeks.
Interventions
Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.
Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- viral Hepatitis B or C
- hemochromatosis
- Wilson Disease
- sclerosing cholangitis
- primary biliary cirrhosis
- other chronic disease
- renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- Abbottcollaborator
- Joint Clinical Research Centercollaborator
- University of Colorado, Denvercollaborator
- University of California, Los Angelescollaborator
Study Sites (1)
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Related Publications (2)
Medici V, Peerson JM, Stabler SP, French SW, Gregory JF 3rd, Virata MC, Albanese A, Bowlus CL, Devaraj S, Panacek EA, Rahim N, Richards JR, Rossaro L, Halsted CH. Impaired homocysteine transsulfuration is an indicator of alcoholic liver disease. J Hepatol. 2010 Sep;53(3):551-7. doi: 10.1016/j.jhep.2010.03.029. Epub 2010 May 31.
PMID: 20561703RESULTMedici V, Virata MC, Peerson JM, Stabler SP, French SW, Gregory JF 3rd, Albanese A, Bowlus CL, Devaraj S, Panacek EA, Richards JR, Halsted CH. S-adenosyl-L-methionine treatment for alcoholic liver disease: a double-blinded, randomized, placebo-controlled trial. Alcohol Clin Exp Res. 2011 Nov;35(11):1960-5. doi: 10.1111/j.1530-0277.2011.01547.x.
PMID: 22044287RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Relatively small numbers of subjects analyzed with 13 each completers in the treatment and placebo groups. Within each group, violation of protocal by resumption of alcohol intake accounted for dropouts.
Results Point of Contact
- Title
- Dr. Charles H. Halsted
- Organization
- University of California Davis
Study Officials
- PRINCIPAL INVESTIGATOR
Charles H Halsted, MD
University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2007
First Posted
December 14, 2007
Study Start
September 1, 2005
Primary Completion
June 1, 2009
Study Completion
September 1, 2009
Last Updated
May 30, 2017
Results First Posted
June 10, 2013
Record last verified: 2017-05