Effects of Iron on Exercise Capacity During Hypoxia
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|ClinicalTrials.gov Identifier: NCT01265108|
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Iron sucrose. Drug: Normal saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Intravenous iron sucrose
Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.
Drug: Iron sucrose.
Volunteers will receive an intravenous infusion of 200 mg iron sucrose, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
Other Name: Iron sucrose = Venofer
Placebo Comparator: Intravenous normal saline
Infusion of 100 ml normal (0.9%) saline.
Drug: Normal saline
Volunteers will receive an intravenous infusion of 100 ml normal saline, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
- Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption. [ Time Frame: 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.
- Maximal exercise capacity, assessed by peak power output. [ Time Frame: After 8-h exposure to alveolar hypoxia. ]
- Pulmonary artery systolic pressure. [ Time Frame: After 8-h exposure to alveolar hypoxia. ]
- Blood levels of oxygen-regulated proteins. [ Time Frame: After 8-h exposure to alveolar hypoxia ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265108
|Department of Physiology, Anatomy & Genetics, University of Oxford|
|Oxford, United Kingdom, OX1 3PT|
|Principal Investigator:||Nick P Talbot, DPhil MRCP||University of Oxford|