S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease

Not Applicable

• Conditions: Alcoholic Liver Diseases
• Interventions: Dietary Supplement: formulation containing S-Adenosyl methionine and choline; Dietary Supplement: Placebo

• Registration Number: NCT03938662
• Lead Sponsor: University Clinic Dr Dragisa Misovic-Dedinje

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.

Study Timeline

• Study First Submitted: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-05-09
• Last Update Submitted: 2019-05-25
• Last Update Posted: 2019-05-29
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• alcoholic liver disease

Exclusion Criteria

• hepatitis B
• hepatitis C
• autoimmune hepatitis
• hemochromatosis
• Wilson's disease
• hepatocellular carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-Adenosyl methionine and choline	formulation containing S-Adenosyl methionine and choline	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.
Placebo	Placebo	Patients in will be administered with placebo once daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT)	24 weeks	Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Clinic Dr Dragisa Misovic-Dedinje; 🇷🇸 Belgrade, Serbia