Optimization of Selenoprotein P in Chinese Subjects
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
20 µg selenium as selenomethionine
干预措施: 20 µg selenium (Dietary Supplement)
2
40 µg selenium as selenomethionine
干预措施: 40 µg selenium (Dietary Supplement)
3
60 µg selenium as selenomethionine
干预措施: 60 µg selenium (Dietary Supplement)
4
80 µg selenium as selenomethionine
干预措施: 80 µg selenium (Dietary Supplement)
5
100 µg selenium as selenomethionine
干预措施: 100 µg selenium (Dietary Supplement)
6
120 µg selenium as selenomethionine
干预措施: 120 µg selenium (Dietary Supplement)
7
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)
