Randomised Controlled Trial Assessing the Effect of S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Alanine aminotransferase (ALT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •alcoholic liver disease
排除标准
- •hepatitis B
- •hepatitis C
- •autoimmune hepatitis
- •hemochromatosis
- •Wilson's disease
- •hepatocellular carcinoma
研究组 & 干预措施
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.
干预措施: formulation containing S-Adenosyl methionine and choline (Dietary Supplement)
Placebo
Patients in will be administered with placebo once daily for 24 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Alanine aminotransferase (ALT)
时间窗: 24 weeks
Alanine aminotransferase will be measured at the enrolment and after 24 weeks of treatment.
次要结局
- Aspartate aminotransferase (AST)(24 weeks)
- Gamma-glutamyl transferase (GGT)(24 weeks)
- Alkaline phosphatase (ALP)(24 weeks)
- Serum bilirubin(24 weeks)
研究者
Nikola Panic
Principal investigator
University Clinic Dr Dragisa Misovic-Dedinje