急性促红细胞生成素对能量不足下军事相关运动后铁调素和膳食铁吸收的影响：初步研究 (IRON BOOST)
急性促红细胞生成素对能量缺乏状态下军事相关运动后铁调素及膳食铁吸收的影响：初步研究
Military personnel frequently experience declines in iron status during training and when in the field, which may compromise performance. The overall purpose of this study is to determine why the decline in iron status occurs and potential countermeasures. Participants will be given an acute dose of erythropoietin (EPO) or placebo and will complete a 90-minute load carriage exercise test. Prior to the main trial, this pilot study will determine the optimal approach to assess iron absorption following exercise (red blood cell incorporation or plasma isotope appearance), the percentage of iron incorporated into red blood cells with EPO compared to placebo, and the timing of the intervention.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Louisiana
-
Baton Rouge、Louisiana、美国、70808
- LSU Pennington Biomedical Research Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males and premenopausal females ages 18-45 years
- Physically active
Exclusion Criteria:
- Low iron stores (ferritin <15 mg/mL)
- Anemia (females: hemoglobin < 12 g/dL, males: hemoglobin < 13 g/dL)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：EPO
Recombinant human erythropoietin (EPO) |
90-minute load carriage exercise test on a treadmill |
|
安慰剂比较：Placebo
Saline placebo |
90-minute load carriage exercise test on a treadmill |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fractional iron absorption
大体时间：14 days post-exercise
|
Iron absorption as measured by iron incorporation into red blood cells |
14 days post-exercise
|
|
Plasma isotope appearance
大体时间：0, 30, 60, 90, 120, 180, and 360 minutes post-exercise
|
Plasma iron isotope appearance |
0, 30, 60, 90, 120, 180, and 360 minutes post-exercise
|
|
Red blood cell iron incorporation
大体时间：50 minutes infusion of a stable iron isotope following exercise
|
The calculation to determine dietary iron absorption accounts for the fact that not all absorbed iron is incorporated into red blood cells. This can either be an assumed constant of 80% or experimentally determined by administering a second isotope intravenously. Pilot testing will be used to assess whether the investigators can use 80% or whether iron uptake by red blood cells is greater after EPO compared to placebo. |
50 minutes infusion of a stable iron isotope following exercise
|
|
Timing of intervention
大体时间：1, 2, 3, 7, 14, 21, and 30 days following EPO
|
Blood will be collected over time to ensure blood biomarkers return to baseline following EPO. |
1, 2, 3, 7, 14, 21, and 30 days following EPO
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.