Actively Recruiting
Intravenous Iron Effects on Performance at High Altitude
Led by United States Army Research Institute of Environmental Medicine · Updated on 2025-03-30
24
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Intravenous Iron Effects on Performance at High Altitude
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman aged 18 to 40 years
- Body mass index between 18.5 and 30 kg/m2
- In good health as confirmed by medical clearance
- Passed recent Army Combat Fitness Test if military, or exercises at least two times per week and can complete 2-mile run in 21 minutes or less if civilian
- Willing to avoid exercise and alcoholic or caffeinated beverages 24 hours before testing sessions
- Willing to avoid strenuous exercise for 36 hours before testing sessions
You will not qualify if you...
- Pregnant women or planning pregnancy during the study
- Taking prescription or over-the-counter medications other than contraceptives without approval
- Taking dietary supplements without approval
- Born at altitudes higher than 2100 meters (7000 feet)
- Living in or traveling to areas above 1200 meters (4000 feet) for five days or more within two months
- Prior diagnosis of High Altitude Pulmonary or Cerebral Edema
- Musculoskeletal injuries limiting treadmill walking or running
- Abnormal hemoglobin S or sickle cell trait
- Hemoglobin outside specified ranges (men: <13.5 or >17.7 g/dL; women: <12.5 or >15.9 g/dL)
- Ferritin levels below 50 ng/mL or above 150 ng/mL
- History of malignancy
- Personal or family history of blood clots or thromboembolic disease
- Hypertension or cardiovascular risk factors
- Blood donation within 8 weeks before study
- History of seizures or inflammatory bowel disease
- Recent or expected prolonged immobility or surgery
- Abnormal blood clotting tests
- Nicotine or recreational drug use unless quit more than 1 month prior
- Recent respiratory infections or cold symptoms
- Allergy to skin adhesive
- Sleep apnea or sleeping disorders
- Current alcoholism or substance abuse
- Body mass under 50 kg (110.5 lbs)
- History of hyperparathyroidism, vitamin D deficiency, or systemic inflammatory diseases
- Drug allergies or hypersensitivity reactions
- History of asthma, kidney or liver disease
- Any previous intravenous iron injection before the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
USARIEM
Natick, Massachusetts, United States, 01760
Actively Recruiting
Research Team
R
Roy Salgado, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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