Alcoholic Liver Diseases
Conditions
Keywords
alcoholic liver diseases, S-Adenosyl methionine, choline
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.
Detailed description
Choline and S-Adenosyl methionine are nutrients both showing hepatoprotective effects. Choline helps liver metabolise glucose and lipids and repair cell membrane. S-Adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. Furthermore S-Adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. It also enables endogenous production of small amount of choline. Although human organism has capacity for production of small amount of S-Adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts. Having this in mind it can be hypothesised that administration of choline and S-Adenosyl methionine can be beneficial in patients with alcoholic liver disease.
Interventions
DIETARY_SUPPLEMENTformulation containing S-Adenosyl methionine and choline
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo of same appearance, colour and taste,
Sponsors
University Clinic Dr Dragisa Misovic-Dedinje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* alcoholic liver disease
Exclusion criteria
* hepatitis B * hepatitis C * autoimmune hepatitis * hemochromatosis * Wilson's disease * hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alanine aminotransferase (ALT) | 24 weeks | Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate aminotransferase (AST) | 24 weeks | Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment. |
| Gamma-glutamyl transferase (GGT) | 24 weeks | Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment. |
| Alkaline phosphatase (ALP) | 24 weeks | Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment. |
| Serum bilirubin | 24 weeks | Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum albumins | 24 week | Serum albumins will be measured at the enrolment and after 24 weeks of treatment. |
| Serum cholesterol | 24 week | Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment. |
| Serum triglycerides | 24 week | Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment. |
| Serum proteins | 24 week | Serum proteins will be measured at the enrolment and after 24 weeks of treatment. |
Countries
Serbia
Contacts
Primary ContactNikola Panic, PhD
Outcome results
None listed