Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
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 tablet
干预措施: placebo (Dietary Supplement)
3
200 µg selenium as selenomethionine
干预措施: selenium (Dietary Supplement)
2
400 µg selenium as selenate
干预措施: selenium (Dietary Supplement)
1
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
