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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03938662
Other study ID # UCDragisaMisovic
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT01701687 - Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease N/A