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

Alcoholic Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938662
• Other study ID #: UCDragisaMisovic
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2019
• Source: University Clinic Dr Dragisa Misovic-Dedinje
• Contact: Nikola Panic, PhD
• Phone: +381 11 3630600
• Email: nikola.panicmail[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• alcoholic liver disease

Exclusion Criteria:

• hepatitis B

• hepatitis C

• autoimmune hepatitis

• hemochromatosis

• Wilson's disease

• hepatocellular carcinoma

Related Conditions & MeSH terms

• Alcoholic Liver Diseases
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Dietary Supplement:
• formulation containing S-Adenosyl methionine and choline
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
• Placebo
Placebo of same appearance, colour and taste,

Locations

Country	Name	City	State
Serbia	University Clinic Dr Dragisa Misovic-Dedinje	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic Dr Dragisa Misovic-Dedinje

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum proteins	Serum proteins will be measured at the enrolment and after 24 weeks of treatment.	24 week
Other	Serum albumins	Serum albumins will be measured at the enrolment and after 24 weeks of treatment.	24 week
Other	Serum cholesterol	Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment.	24 week
Other	Serum triglycerides	Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment.	24 week
Primary	Alanine aminotransferase (ALT)	Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.	24 weeks
Secondary	Aspartate aminotransferase (AST)	Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment.	24 weeks
Secondary	Gamma-glutamyl transferase (GGT)	Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment.	24 weeks
Secondary	Alkaline phosphatase (ALP)	Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment.	24 weeks
Secondary	Serum bilirubin	Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment.	24 weeks