Influence of Selenium on Prostate Cancer Related Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Biomarkers of oxidative stress
研究概览
简要总结
Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of two different forms of selenium (selenium yeast and selenomethionine) on blood selenium levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of getting prostate cancer in their lifetime. Participants will be asked to take over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of twelve months.
详细描述
We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched yeast (SY) (200 µg/day and 285 µg/day) for 9 months; the 285 µg/day SY is selected to deliver an equivalent selenium as in 200 µg/day SM to healthy men. The variability of SM in SY that will be used here is less than 3% and it accounts for 70.5% of the SM content in SY. As primary endpoints, we will determine the effects of these two forms of selenium on plasma levels of selenium and its metabolites as well as biomarkers of oxidative stress at several time points. As a secondary endpoint, the effect of these two forms of selenium on plasma PSA levels will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No history or evidence of diabetes
- •Male between the ages of 20-79
- •PSA levels ≤ 4.0 ng/mL
- •Not taking >50 µg/day selenium as a dietary supplement including multi- vitamins
- •Non-smoker
- •No concurrently participating or have participated in any other clinical trial within at least 30 days of registration
- •Health male
排除标准
- •Evidence of prostate cancer
- •Evidence of liver or kidney disease
结局指标
主要结局
Biomarkers of oxidative stress
时间窗: 12 months
次要结局
- Plasma levels of selenium and selenium metabolites(12 months)
- PSA(12 months)
- Plasma Glucose(12 months)
研究者
Karam El-Bayoumy
Professor of Biochemical and Molecular Biology
Milton S. Hershey Medical Center