Intravenous Iron Prophylaxis for Rapid High Altitude Insertions

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
USARIEM
RECRUITING
Natick
Contact Information
Primary
Roy Salgado, PhD
roy.m.salgado.civ@health.mil
508-206-2375
Time Frame
Start Date: 2022-04-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 24
Treatments
Experimental: Placebo
Placebo - saline
Experimental: Intravenous iron
Iron - Injectafer 15 mg/kg up to 1000 mg
Related Therapeutic Areas
Sponsors
Leads: United States Army Research Institute of Environmental Medicine

This content was sourced from clinicaltrials.gov