A Phase 4 interventional study of Injectafer and Placebo in Hypoxia, sponsored by United States Army Research Institute of Environmental Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by United States Army Research Institute of Environmental Medicine · Phase 4, Interventional, and Other
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
This study will use a double-blind randomized study design in which one group will receive iron (n = 12; Injectafer, 15 mg/kg up to 1000 mg) and the other a placebo (n = 12; saline). Twenty-four participants will complete seven study visits: Visit 1: Orientation visit consisting of dual-energy X-ray absorptiometry scan (DEXA), pulmonary function test, assessment of peak aerobic capacity (VO2peak); Visits 2-3: familiarization consisting of exercise battery (20 minutes of walking followed by 2 mile treadmill time trial); Visits 4, 6-7: high altitude trial (4,800 m) in which skin blood flow during rest will be measured, ventilation at sea level and altitude will be assessed, collection of sea level and altitude arterialized capillary and venous blood will be collected, and the exercise battery. Visit 5: participants will receive the iron or placebo.
Man or woman, age 18-40 years
Exclusion Criteria:
Women who are pregnant or planning to become pregnant during the study
Placebo - saline
Other: Placebo
Iron - Injectafer 15 mg/kg up to 1000 mg
Drug: Injectafer
Injectafer - 15 mg/kg up to 1000 mg
Placebo
2 mile treadmill time trial performance
Time to complete self-paced 2 miles treadmill time trial (min:sec)
Time frame: Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.
Ventilation rate
Ventilation rate will be assessed using a pneumotachometer (l/min).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Percent body fat
Percent body fat will be assessed using Dual Energy X-ray Absorptiometry (%body fat).
Time frame: Will be assessed once at the beginning of the study.
Oxygen Saturation
Oxygen saturation will be assessed using a finger pulse oximeter (%).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Hematocrit
Hematocrit will be assessed using manual hematocrit method (%).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Ferritin
Ferritin will be assessed using an ELISA (ng/ml).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
C-reactive protein
C-reactive protein will be assessed using an ELISA (mg/L).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Soluble transferrin
Soluble transferrin will be assessed using an ELISA (mg/L).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PO2
Arterialized capillary PO2 will be assessed using a blood gas analyzer (mmHg).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PCO2
Arterialized capillary PCO2 will be assessed using a blood gas analyzer (mmHg).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary pH
Arterialized capillary pH will be assessed using a blood gas analyzer.
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Skin Blood flow
Skin blood flow will be assessed via laser doppler (arbitrary units).
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
VO2peak
Peak aerobic capacity will be assessed using a metabolic cart (ml/kg/min and or l/min).
Time frame: Will be assessed once on day 1.
Pulmonary function test
Pulmonary function test will be performed to determine forced vital capacity (FVC; L) using a metabolic cart.
Time frame: Will be assessed once on day 1.
Pulmonary function test
Pulmonary function test will be performed to determine forced expired volume in one second (FEV1; L) using a metabolic cart.
Time frame: Will be measured once on day 1.
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United States Army Research Institute of Environmental Medicine