Description of Iron Status in Blood Donors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Iron status
研究概览
简要总结
Description of the effect of standard iron supplement on iron status in blood donors
Hypothesis:
For each person in each group (group a "without iron supplement" or group b "with iron supplement") individual biological variation in reticulocytes, tested day 1 and day 8 will be described. Groups a and b will be compared on iron status from day 1 and day 8.
- H1 null: There is no significant intraindividual difference in reticstatus at day 1 and at day 8, in group a.
- H2 null: There is no significant intraindividual difference in reticstatus at day 1 and at day 8, in group b
- H3 null: There is no significant difference in iron status for the two groups, a and b, at day 1 and at day 8.
详细描述
The purpose of the study:
The purpose of the study is to describe intra- individual biological variation in reticulocyte parameters in established blood donors. The aim is also to compare iron status and reticulocyte parameters in a group of established donors who are offered iron supplement, to a comparable group who are not offered iron supplement, at the time of donation and one week after donation.
Design:
The design is a prospective longitudinal intervention-study, with randomised subjects to iron supplement/ not iron supplement groups.
Materials and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be accepted as blood donor
排除标准
- 未提供
结局指标
主要结局
Iron status
时间窗: april 2008
次要结局
- Hemoglobin and serum ferritin(april 2008)