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临床试验/NCT00428649
NCT00428649已完成不适用

Optimization of Selenoprotein P in Chinese Subjects

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2007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
已完成
入组人数
98
试验地点
1
主要终点
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

研究概览

简要总结

The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects

详细描述

Selenium is an essential nutrient. The Recommended Dietary Allowance (RDA) for selenium is considered to be the amount required to optimize plasma selenoproteins. There are two selenoproteins present in the plasma: selenoprotein P (Se-P) and glutathione peroxidase 3 (GPX-3). Although the amount of selenium required to optimize GPX-3 has been determined, the amount required to optimize Se-P in the plasma remains unknown. We aim to determine this amount by supplementing selenium deficient subjects with varying amounts of selenium as selenomethionine.

The study will take place in Mianning County, China, where selenium status is low. Approximately 150 people will be screened for eligibility to participate in this study. 98 subjects will be enrolled. Background information obtained from each participant will be: age, height, weight and smoking status.

Subjects will be randomized to a selenium supplement group. The selenium supplement will contain either 0, 20, 40, 60, 80, 100, or 120 µg of selenium as selenomethionine. A CDC worker will visit each participant daily to give them their selenium supplement. The CDC worker will watch them take their supplement and will ask if they have any unanticipated problems. Blood samples of 20 ml will be obtained at weeks 0, 4, 8, 12, 16, 20, 24, 32, and 40. Hair samples and 24-hr urine collections will be obtained at 0, 20 and 40 weeks. The total study duration is 40 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •aged 17 years or older
  • •resident of Mianning County for at least 1 year
  • •hematocrit (PCV) of 30 or greater

排除标准

  • •subject has taken selenium supplements within the year prior to study
  • •subject plans to relocate during study

研究组 & 干预措施

1

Experimental

20 µg selenium as selenomethionine

干预措施: 20 µg selenium (Dietary Supplement)

2

Experimental

40 µg selenium as selenomethionine

干预措施: 40 µg selenium (Dietary Supplement)

3

Experimental

60 µg selenium as selenomethionine

干预措施: 60 µg selenium (Dietary Supplement)

4

Experimental

80 µg selenium as selenomethionine

干预措施: 80 µg selenium (Dietary Supplement)

5

Experimental

100 µg selenium as selenomethionine

干预措施: 100 µg selenium (Dietary Supplement)

6

Experimental

120 µg selenium as selenomethionine

干预措施: 120 µg selenium (Dietary Supplement)

7

Placebo Comparator

placebo

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

时间窗: 40 weeks

次要结局

  • Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks(40 weeks)
  • Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks(40 weeks)
  • 24hr urinary selenium excretion at 0, 20 and 40 weeks(40 weeks)
  • Hair selenium levels at 0, 20 and 40 weeks(40 weeks)

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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