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

May 25, 2019 updated by: Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinic Dr Dragisa Misovic-Dedinje
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • alcoholic liver disease

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Comparator: Placebo
Patients in will be administered with placebo once daily for 24 weeks.
Dietary supplement: Placebo
Placebo of same appearance, colour and taste,

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum proteins
Time Frame: 24 week
Serum proteins will be measured at the enrolment and after 24 weeks of treatment.
24 week
Serum albumins
Time Frame: 24 week
Serum albumins will be measured at the enrolment and after 24 weeks of treatment.
24 week
Serum cholesterol
Time Frame: 24 week
Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment.
24 week
Serum triglycerides
Time Frame: 24 week
Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment.
24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Dr Dragisa Misovic-Dedinje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 25, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCDragisaMisovic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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