Intravenous Iron Effects on Performance at High Altitude
ConditionHypoxia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUnited States Army Research Institute of Environmental Medicine
About this trial
To compare the effects of IV iron versus placebo (saline) injection on arterial oxygen saturation, submaximal exercise responses, and 2-mile treadmill time-trial performance during acute exposure to hypobaric hypoxia (430 mmHg, simulating \~4800m) assessed 1 and 14 days after treatment.
Primary Hypothesis 1: IV iron treatment will improve arterial oxygen saturation at rest and during exercise in acute hypobaric hypoxia and this effect will persist for 2 weeks
Primary Hypothesis 2) IV iron treatment will improve 2-mile treadmill time trial performance in acute hypobaric hypoxia and this effect will persist for 2 weeks
Eligibility criteria
Qualifiers
Man or woman, age 18-40 years
BMI 18.5-30 kg/m2
In good health as determined by the Office of Medical Support & Oversight (OMSO) General Medical Clearance
Passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only) or exercises at least 2 times per week and able to complete two mile run in ≤ 21 minutes (Civilian Volunteers)
Disqualifiers
Women who are pregnant or planning to become pregnant during the study
Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO & PI
Taking dietary supplements unless approved by OMSO & PI
Born at altitudes greater than 2,100 m (7,000 ft)
Trial design
Treatments tested in this trial
- Injectafer
- Placebo
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov