Intravenous Iron Prophylaxis for Rapid High Altitude Insertions
United States Army Research Institute of Environmental Medicine
Summary
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
Description
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 durin…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
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 Cr…
Interventions
- DrugInjectafer
Injectafer - 15 mg/kg up to 1000 mg
- OtherPlacebo
Placebo
Location
- USARIEMNatick, Massachusetts