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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-Adenosyl methionine and choline | Experimental | 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 Comparator | Patients in will be administered with placebo once daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| formulation containing S-Adenosyl methionine and choline | Dietary Supplement | Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase (ALT) | Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment. | 24 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum proteins | Serum proteins will be measured at the enrolment and after 24 weeks of treatment. | 24 week |
| Serum albumins | Serum albumins will be measured at the enrolment and after 24 weeks of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikola Panic, PhD | Contact | +381 11 3630600 | nikola.panicmail@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Dr Dragisa Misovic-Dedinje | Recruiting | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D002794 | Choline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Dietary Supplement | Placebo of same appearance, colour and taste, |
|
| 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 |
| 24 week |
| Serum cholesterol | Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment. | 24 week |
| Serum triglycerides | Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment. | 24 week |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000588 |
| Amines |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |