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

University Clinic Dr Dragisa Misovic-Dedinje

Status: Unknown

Conditions: Alcoholic Liver Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: formulation containing S-Adenosyl methionine and choline

Study type: Interventional

Funder types: Other

Identifiers

NCT03938662

UCDragisaMisovic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• alcoholic liver disease

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

S-Adenosyl methionine and choline

Experimental group

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.

Treatment:

Dietary Supplement: formulation containing S-Adenosyl methionine and choline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo