Intravenous Iron Effects on Performance at High Altitude

Part of paid clinical trials in Natick, Massachusetts.

Sponsor
United States Army Research Institute of Environmental Medicine
Study ID
NCT06686693
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypoxia

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Injectafer — DRUG
    Injectafer - 15 mg/kg up to 1000 mg
  • Placebo — OTHER
    Placebo

Study Details

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 Dates

Start date
Apr 15, 2022
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Placebo
    Placebo - saline
  • Experimental: Intravenous iron
    Iron - Injectafer 15 mg/kg up to 1000 mg

Primary Outcome Measure

2 mile treadmill time trial performance [ Time Frame: Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USARIEMNatickMassachusetts01760
Roy M Salgado, Ph.D.
[email protected]
508-206-2375

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