Hemoglobin and Iron Recovery Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 8
- 主要终点
- Time to recovery of hemoglobin after blood donation
研究概览
简要总结
The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.
详细描述
The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (<60 years old vs. at least 60 years old) and iron status (serum ferritin >26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •potential blood donors with hemoglobin of at least 12.5 gm/dL
- •no blood donation for at least 4 months
- •successful donation of a unit of whole blood
排除标准
- •individuals who are taking iron supplements including multivitamins containing iron and refuse to stop do so for the 24 weeks of the study.
- •baseline ferritin >300 ug/L (to exclude individuals with hemochromatosis)
结局指标
主要结局
Time to recovery of hemoglobin after blood donation
时间窗: Up to 24 weeks after blood donation
Hemoglobin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of hemoglobin to 80% of the pre-donation level.
次要结局
- Iron stores(Up to 24 weeks after blood donation)
- Total body iron(24 weeks after blood donation)