Intravenous Iron Effects on Performance at High Altitude

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Hypoxia

In brief

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

Key facts

Study ID

NCT06686693

Run by

United States Army Research Institute of Environmental Medicine

People needed

24

Starts

2022-04-15

Expected to finish

2025-09-30

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• USARIEM — Natick, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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