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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 24 is below the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →United States Army Research Institute of Environmental Medicine is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Man or woman, age 18-40 years
Exclusion Criteria:
Women who are pregnant or planning to become pregnant during the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Apr 2022 (actual). Primary completion is estimated for Sep 2025, 41 months after the start.
Of 17 phase 4 interventional studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ferric carboxymaltose
United States Army Research Institute of Environmental Medicine