drugset / Trial / NCT05300477

Pharmacological Countermeasures for High Altitude

NCT05300477

RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2022-05-27
Primary completion
2023-09-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetazolamide Small molecule 250 mg Oral
Subject epoetin alfa Protein / enzyme biologic 50 iu/kg Subcutaneous