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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease

Conditions
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Alcoholic Liver Diseases

Intervention / Treatment
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* Dietary Supplement: formulation containing S-Adenosyl methionine and choline
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: alcoholic liver disease Exclusion Criteria: hepatitis B hepatitis C autoimmune hepatitis hemochromatosis Wilson's disease hepatocellular carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-Adenosyl methionine and choline<br>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. | Dietary Supplement: formulation containing S-Adenosyl methionine and choline<br>* Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.<br>|
| Placebo Comparator: Placebo<br>Patients in will be administered with placebo once daily for 24 weeks. | Dietary Supplement: Placebo<br>* Placebo of same appearance, colour and taste,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alanine aminotransferase (ALT) | Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspartate aminotransferase (AST) | Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | 
| Gamma-glutamyl transferase (GGT) | Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | 
| Alkaline phosphatase (ALP) | Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | 
| Serum bilirubin | Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholic liver diseases, S-Adenosyl methionine, choline