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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938662
Recruitment Status : Unknown
Verified May 2019 by Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje.
Recruitment status was:  Recruiting
First Posted : May 6, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alcoholic Liver Diseases Dietary Supplement: formulation containing S-Adenosyl methionine and choline Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arms and Interventions
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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,


Outcome Measures
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Primary Outcome Measures :
  1. Alanine aminotransferase (ALT) [ Time Frame: 24 weeks ]
    Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.


Secondary Outcome Measures :
  1. Aspartate aminotransferase (AST) [ Time Frame: 24 weeks ]
    Aspartate aminotransferase will be measured at the enrolment and after 24 weeks of treatment.

  2. Gamma-glutamyl transferase (GGT) [ Time Frame: 24 weeks ]
    Gamma-glutamyl transferase will be measured at the enrolment and after 24 weeks of treatment.

  3. Alkaline phosphatase (ALP) [ Time Frame: 24 weeks ]
    Alkaline phosphatase will be measured at the enrolment and after 24 weeks of treatment.

  4. Serum bilirubin [ Time Frame: 24 weeks ]
    Bilirubin levels will be measured at the enrolment and after 24 weeks of treatment.


Other Outcome Measures:
  1. Serum proteins [ Time Frame: 24 week ]
    Serum proteins will be measured at the enrolment and after 24 weeks of treatment.

  2. Serum albumins [ Time Frame: 24 week ]
    Serum albumins will be measured at the enrolment and after 24 weeks of treatment.

  3. Serum cholesterol [ Time Frame: 24 week ]
    Serum cholesterol will be measured at the enrolment and after 24 weeks of treatment.

  4. Serum triglycerides [ Time Frame: 24 week ]
    Serum triglycerides will be measured at the enrolment and after 24 weeks of treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • alcoholic liver disease

Exclusion Criteria:

  • hepatitis B
  • hepatitis C
  • autoimmune hepatitis
  • hemochromatosis
  • Wilson's disease
  • hepatocellular carcinoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938662


Contacts
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Contact: Nikola Panic, PhD +381 11 3630600 nikola.panicmail@gmail.com

Locations
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Serbia
University Clinic Dr Dragisa Misovic-Dedinje Recruiting
Belgrade, Serbia, 11000
Contact: Nikola Panic, PhD    +381643509133    nikola.panicmail@gmail.com   
Sponsors and Collaborators
University Clinic Dr Dragisa Misovic-Dedinje
More Information
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Responsible Party: Nikola Panic, Principal investigator, University Clinic Dr Dragisa Misovic-Dedinje
ClinicalTrials.gov Identifier: NCT03938662    
Other Study ID Numbers: UCDragisaMisovic
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nikola Panic, University Clinic Dr Dragisa Misovic-Dedinje:
alcoholic liver diseases
S-Adenosyl methionine
choline
Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Choline
 Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents