S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
NCT ID: NCT03938662
Last Updated: 2019-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2019-05-09
2020-04-01
Brief Summary
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Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
Patients in will be administered with placebo once daily for 24 weeks.
Placebo
Placebo of same appearance, colour and taste,
Interventions
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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,
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* hepatitis C
* autoimmune hepatitis
* hemochromatosis
* Wilson's disease
* hepatocellular carcinoma
18 Years
ALL
No
Sponsors
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University Clinic Dr Dragisa Misovic-Dedinje
OTHER
Responsible Party
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Nikola Panic
Principal investigator
Locations
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University Clinic Dr Dragisa Misovic-Dedinje
Belgrade, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UCDragisaMisovic
Identifier Type: -
Identifier Source: org_study_id
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