S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
1 other identifier
interventional
44
1 country
1
Brief Summary
The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease. Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
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
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMay 29, 2019
May 1, 2019
11 months
April 30, 2019
May 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alanine aminotransferase (ALT)
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
24 weeks
Secondary Outcomes (4)
Aspartate aminotransferase (AST)
24 weeks
Gamma-glutamyl transferase (GGT)
24 weeks
Alkaline phosphatase (ALP)
24 weeks
Serum bilirubin
24 weeks
Other Outcomes (4)
Serum proteins
24 week
Serum albumins
24 week
Serum cholesterol
24 week
- +1 more other outcomes
Study Arms (2)
S-Adenosyl methionine and choline
EXPERIMENTALPatients in will be administered with formulation of 100 mg of S-Adenosyl methionine and 82.5 mg of choline, once daily for 24 weeks.
Placebo
PLACEBO COMPARATORPatients in will be administered with placebo once daily for 24 weeks.
Interventions
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
Eligibility Criteria
You may qualify if:
- alcoholic liver disease
You may not qualify if:
- hepatitis B
- hepatitis C
- autoimmune hepatitis
- hemochromatosis
- Wilson's disease
- hepatocellular carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic Dr Dragisa Misovic-Dedinje
Belgrade, 11000, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 6, 2019
Study Start
May 9, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
May 29, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share