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临床试验/NCT00212186
NCT00212186已完成不适用

Selenium Supplementation of Patients With Cirrhosis

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 1998年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Plasma Selenium Biomarkers

研究概览

简要总结

The purpose of this study is to determine whether patients with liver disease can improve their nutritional selenium status by taking supplemental selenium.

详细描述

Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium requirements and may benefit from additional selenium.

We proposed to compare the effects of two different forms of supplemental selenium on plasma selenium levels among patients with severe liver cirrhosis and healthy individuals (controls). Patients and controls were randomly assigned to one of 3 treatment groups: 200 µg selenium per day as selenate, 200 µg selenium per day as selenomethionine, or a placebo. The intervention lasted 8 weeks. Blood was measured initially and after 2 and 4 weeks of supplementation. Selenium, selenoprotein P and glutathione peroxidase were measured in the plasma. We compared changes in selenium and selenoprotein levels between liver cirrhosis patients and healthy controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy Adults
  • •Adults with Child-Pugh Class C liver cirrhosis

排除标准

  • •Diagnosis of renal failure
  • •Urgent need of liver transplant
  • •Selenium supplements of >25 µg per day during the past year

结局指标

主要结局

Plasma Selenium Biomarkers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RBurk

M.D.

Vanderbilt University

研究点 (1)

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