Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
研究概览
简要总结
During alveolar hypoxia, for example at high altitude or in patients with respiratory disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit exercise performance. Intravenous iron supplementation has recently been shown to reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized that intravenous iron supplementation would enhance exercise capacity during alveolar hypoxia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years
- •Sea level natives with no recent exposure to high altitude
- •Baseline iron indices within the normal range
- •Detectable tricuspid regurgitation on echocardiography
排除标准
- •Significant cardiorespiratory disease
- •Known susceptibility to high altitude-related illness
- •Taking medications or iron supplementation
- •Pregnancy
研究组 & 干预措施
Intravenous iron sucrose
Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.
干预措施: Iron sucrose. (Drug)
Intravenous normal saline
Infusion of 100 ml normal (0.9%) saline.
干预措施: Normal saline (Drug)
结局指标
主要结局
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
时间窗: After 8-h exposure to alveolar hypoxia.
Volunteers will receive either intravenous iron or saline placebo, before exposure to 8 hours of alveolar hypoxia. They will then undergo an exercise test while breathing an hypoxic gas mixture. The primary outcome measure will be exercise capacity as determined by maximal oxygen consumption during this test. Volunteers will receive both interventions, via a crossover design. Due to uncertainty about the duration of action of iron at a cellular level, all volunteers will receive saline infusion on the first study day, and iron sucrose infusion on a second study day, at least one week later.
次要结局
- Maximal exercise capacity, assessed by peak power output.(After 8-h exposure to alveolar hypoxia.)
- Pulmonary artery systolic pressure.(After 8-h exposure to alveolar hypoxia.)
- Blood levels of oxygen-regulated proteins.(After 8-h exposure to alveolar hypoxia)