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
Lead SponsorUniversity Clinic Dr Dragisa Misovic-Dedinje
Indication/ConditionAlcoholic Liver Diseases
Intervention/Treatmentformulation containing S-Adenosyl methionine and choline [choline (115235), s-adenosyl methionine (116313)] ...
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.
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,
Patients in will be administered with formulation of 100 mg of S-Adenosyl methionine and 82.5 mg of choline, once daily for 24 weeks.
Patients in will be administered with placebo once daily for 24 weeks.
Inclusion Criteria: alcoholic liver disease Exclusion Criteria: hepatitis B hepatitis C autoimmune hepatitis hemochromatosis Wilson's disease hepatocellular carcinoma