Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 491
- 试验地点
- 2
- 主要终点
- Viability of full scale study
研究概览
简要总结
This is a pilot study proceeding an intended international trial.
Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.
Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.
AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •WHO performance status 0 or 1
- •No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
- •No previous cancer diagnosis
- •No known HIV-infection
- •Participant must understand oral and written information
- •Participant must not use selenium supplementation of above 50 mcg/d
- •Participant must give written consent prior to inclusion
排除标准
- 未提供
结局指标
主要结局
Viability of full scale study
时间窗: At five years intervention
At five years intervention (last participant last visit was june 2004) viability of full scale study was assessed according to the drop out rate, cost etc. of this pilot study.
次要结局
- AMENDMENT TO OUTCOME MEASURES: Mortality analysis.(Up to 17 years)
研究者
Søren Cold
M.D. PhD
Odense University Hospital