Selenium Supplementation of Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
研究概览
简要总结
The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.
详细描述
Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The liver converts dietary selenium to a form that can be used to make selenoproteins. Patients with cirrhosis have much lower selenium levels than healthy individuals. We hypothesize that patients with cirrhosis are unable to utilize dietary selenium for selenoprotein synthesis. These patients may benefit from another form of selenium: selenate.
We will compare the effects of two supplemental forms of selenium on plasma selenium levels in patients with cirrhosis. Patients will be randomized to receive either a placebo, 200 µg selenomethionine, 200 µg selenate or 400 µg selenate, daily, for 8 weeks. We will measure selenium levels in the blood at baseline, week 4 and week 8. We will determine which forms of selenium, if any, increased plasma selenium levels of the cirrhosis patients.
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
- •liver disease
- •aged 18 or above
排除标准
- •substance abuse
- •renal failure
研究组 & 干预措施
1
200 µg selenium as selenate
干预措施: 200 µg selenium as selenate (Dietary Supplement)
2
400 µg selenium as selenate
干预措施: 400 µg selenium as selenate (Dietary Supplement)
3
200 µg selenium as selenomethionine
干预措施: 200 µg selenium as selenomethionine (Dietary Supplement)
4
placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
时间窗: 8 week
次要结局
未报告次要终点