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临床试验/NCT00212212
NCT00212212终止不适用

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2006年3月1日最近更新:
适应症
干预措施

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 selenium biomarkers

研究概览

简要总结

This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.

详细描述

Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet.

We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

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

  • •adults with cirrhosis

排除标准

  • •Pregnancy or planning a pregnancy
  • •Selenium supplements of 25 µg or more within the past year

研究组 & 干预措施

4

Placebo Comparator

placebo tablet

干预措施: placebo (Dietary Supplement)

3

Experimental

200 µg selenium as selenomethionine

干预措施: selenium (Dietary Supplement)

2

Experimental

400 µg selenium as selenate

干预措施: selenium (Dietary Supplement)

1

Experimental

200 µg selenium as selenate

干预措施: selenium (Dietary Supplement)

结局指标

主要结局

Plasma selenium biomarkers

时间窗: 4 and 8 weeks

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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