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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
Placebo of same appearance, colour and taste,
University Clinic Dr Dragisa Misovic-Dedinje
Belgrade, Serbia
RECRUITINGAlanine aminotransferase (ALT)
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Time frame: 24 weeks
Aspartate aminotransferase (AST)
Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Time frame: 24 weeks
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment.
Time frame: 24 weeks
Alkaline phosphatase (ALP)
Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment.
Time frame: 24 weeks
Serum bilirubin
Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment.
Time frame: 24 weeks
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