Clinical Trial

Pharmacological Countermeasures for High Altitude

Active, Not Recruiting Phase 4
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Summary
The aim of this randomized, double-blind study is to determine whether erythropoietin (Procrit) and acetazolamide: 1) mitigates altitude-induced decrements in performance at moderate altitude (3,000 m) and 2) mitigates altitude-induced decrements in performance and reduce acute mountain sickness during prolonged exposure to high altitude (4,300 m; 15 days). Volunteers will complete 5 study phases: Phase 1) sea level baseline testing and a moderate altitude exposure; Phase 2) 4 week study intervention - randomly assigned to receive erythropoietin or placebo); Phase 3) 3 1/2 days of acetazolamide and a moderate altitude exposure; Phase 4) high altitude acclimatization - 15 days at Pikes Peak; and Phase 5) two week deacclimatization. Test battery include VO2peak, 3.2 km treadmill time trial, measures of gas exchange and ventilation during rest and exercise, and blood collection.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-03-28; most recent amendment 2025-03-25.
Status change: Recruiting → Active, Not Recruiting 2024-07-15
Trial Details
NCT Number NCT05300477
Lead Sponsor United States Army Research Institute of Environmental Medicine
Collaborators: University of Puget Sound
Conditions Hypobaric Hypoxia
Enrollment 18 participants
Start Date 2022-05-27
Primary Completion 2023-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-26