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Intravenous Iron Effects on Performance at High Altitude

RecruitingPhase 4Healthy volunteers welcome

Intravenous Iron Prophylaxis for Rapid High Altitude Insertions

Who can join

Ages 18 to 40 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* 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)
  * Willing to not exercise, or drink alcoholic/caffeinated beverages 24 hours prior to each testing session
  * Willing to not perform any strenuous exercise 36 hours prior to each testing session

Exclusion Criteria:

* 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)
  * Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
  * Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
  * Musculoskeletal injuries that compromise the ability to walk/run on a treadmill
  * Presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
  * Hemoglobin concentration: men: Hb \<13.5 g/dL or Hb \>17.7 g/dL; women Hb \<12.5 g/dL or Hb \>15.9 g/dL
  * Ferritin \< 50 ng/mL or greater than 150 ng/mL
  * Any history of malignancy
  * Personal or family history of blood clots
  * History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease
  * Blood donation within 8 weeks of beginning the study
  * History of seizures
  * History of inflammatory bowel disease
  * Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)
  * Abnormal PT/PTT test or problems with blood clotting
  * Any nicotine or recreational drug use (unless quit \> 1 month prior to study orientation)
  * Presence of respiratory tract infections (\< 1 month prior)
  * Experience recent cold, coughs, or sinus infections (\< 2 weeks prior)
  * Allergy to skin adhesive
  * Evidence of apnea or sleeping disorder
  * Present condition of alcoholism, use of anabolic steroids, other substance abuse issues
  * Body mass \<50 kg (110.5 lbs)
  * History of hyperparathyroidism
  * History of vitamin D deficiency
  * History of systemic inflammatory disease (rheumatoid arthritis, lupus erythematosus)
  * Any drug allergies
  * History of hypersensitivity reaction
  * History of asthma
  * History of kidney or liver disease
  * Any previous intravenous iron injection

About the study

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

What is being tested

Sponsor: United States Army Research Institute of Environmental Medicine · Participants: 24 · Started: Apr 15, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT06686693

Locations in the U.S.

MassachusettsUSARIEM, Natick

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.