Alcoholic Liver Diseases Clinical Trial
Official title:
Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
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.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - alcoholic liver disease Exclusion Criteria: - hepatitis B - hepatitis C - autoimmune hepatitis - hemochromatosis - Wilson's disease - hepatocellular carcinoma |
Country | Name | City | State |
---|---|---|---|
Serbia | University Clinic Dr Dragisa Misovic-Dedinje | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University Clinic Dr Dragisa Misovic-Dedinje |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum proteins | Serum proteins will be measured at the enrolment and after 24 weeks of treatment. | 24 week | |
Other | Serum albumins | Serum albumins will be measured at the enrolment and after 24 weeks of treatment. | 24 week | |
Other | Serum cholesterol | Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment. | 24 week | |
Other | Serum triglycerides | Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment. | 24 week | |
Primary | Alanine aminotransferase (ALT) | Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | |
Secondary | Aspartate aminotransferase (AST) | Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | |
Secondary | Gamma-glutamyl transferase (GGT) | Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | |
Secondary | Alkaline phosphatase (ALP) | Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | |
Secondary | Serum bilirubin | Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01701687 -
Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease
|
N/A |