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UnknownNCT03938662

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
University Clinic Dr Dragisa Misovic-Dedinje · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTformulation containing S-Adenosyl methionine and cholinePatients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
DIETARY_SUPPLEMENTPlaceboPlacebo of same appearance, colour and taste,

Timeline

Start date
2019-05-09
Primary completion
2020-04-01
Completion
2020-04-01
First posted
2019-05-06
Last updated
2019-05-29

Locations

1 site across 1 country: Serbia

Source: ClinicalTrials.gov record NCT03938662. Inclusion in this directory is not an endorsement.