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

Primary Purpose

Alcoholic Liver Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
formulation containing S-Adenosyl methionine and choline
Placebo
Sponsored by
University Clinic Dr Dragisa Misovic-Dedinje
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Liver Diseases focused on measuring alcoholic liver diseases, S-Adenosyl methionine, choline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • alcoholic liver disease

Exclusion Criteria:

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

Sites / Locations

  • University Clinic Dr Dragisa Misovic-DedinjeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-Adenosyl methionine and choline

Placebo

Arm Description

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.

Patients in will be administered with placebo once daily for 24 weeks.

Outcomes

Primary Outcome Measures

Alanine aminotransferase (ALT)
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2019
Last Updated
May 25, 2019
Sponsor
University Clinic Dr Dragisa Misovic-Dedinje
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1. Study Identification

Unique Protocol Identification Number
NCT03938662
Brief Title
S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Official Title
Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinic Dr Dragisa Misovic-Dedinje

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Diseases
Keywords
alcoholic liver diseases, S-Adenosyl methionine, choline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-Adenosyl methionine and choline
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in will be administered with placebo once daily for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
formulation containing S-Adenosyl methionine and choline
Intervention Description
Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo of same appearance, colour and taste,
Primary Outcome Measure Information:
Title
Alanine aminotransferase (ALT)
Description
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Aspartate aminotransferase (AST)
Description
Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 weeks
Title
Gamma-glutamyl transferase (GGT)
Description
Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 weeks
Title
Alkaline phosphatase (ALP)
Description
Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 weeks
Title
Serum bilirubin
Description
Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Serum proteins
Description
Serum proteins will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 week
Title
Serum albumins
Description
Serum albumins will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 week
Title
Serum cholesterol
Description
Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 week
Title
Serum triglycerides
Description
Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment.
Time Frame
24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: alcoholic liver disease Exclusion Criteria: hepatitis B hepatitis C autoimmune hepatitis hemochromatosis Wilson's disease hepatocellular carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikola Panic, PhD
Phone
+381 11 3630600
Email
nikola.panicmail@gmail.com
Facility Information:
Facility Name
University Clinic Dr Dragisa Misovic-Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikola Panic, PhD
Phone
+381643509133
Email
nikola.panicmail@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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