Pharmacological Countermeasures for High Altitude

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Hypobaric Hypoxia

In brief

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.

Key facts

Study ID

NCT05300477

Run by

United States Army Research Institute of Environmental Medicine

People needed

18

Starts

2022-05-27

Expected to finish

2025-09-30

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-40 years
• In good health as determined by the Office of Medical Support \& Oversight (OMSO) General Medical Clearance
• Runs at least 3 times per week and able to complete a two mile run in ≤ 21 minutes (Civilian Volunteers) or passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only)
• Willing to not exercise, or drink alcoholic and/or caffeinated beverages 24 hours prior to each testing session or the acute altitude exposure to 3,000 m
• Abstain from alcoholic beverages during the 15 day residence at the summit of Pikes Peak
• Abstain from drinking alcohol or caffeine at least 24 hours before a testing session during Phases 1 and 3
• Willing to stay and exercise in an altitude chamber (the size of a dorm room) for \~2.5 hours
• Wiling to reside at the summit of Pikes Peak (4,300 m altitude) and share dormitory area (bunk area, shower, and bathroom), potentially with people of the opposite sex for 15 days
• Up to date on COVID-19 vaccination

You may not qualify if…

• Women who are pregnant or planning to become pregnant during the study
• Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO \& PI
• Born at altitudes greater than 2,100 m (7,000 ft)
• Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
• Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
• Musculoskeletal injuries that compromise the ability to walk/run on a treadmill or hike steep terrain
• Abnormal blood count in accordance with OMSO - Normal Hb men: 12.6-17.7 g·dL-1 and women: 11.1-15.9 g·dL-1 or Normal Hct men: 37.5-48% and women: 34.0-45%, or presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
• Any history of malignancy
• Personal or family history of blood clots
• Abnormal prothrombin time/partial thromboplastin time (PT/PTT) test or problems with blood clotting
• History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease
• Blood donation within 8 weeks of beginning the study
• History of seizures
• History of inflammatory bowel disease
• Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)
• No evidence of iron deficiency (ferritin < 45 ng/ml)
• Smokers or tobacco/nicotine (unless quit > 1 month prior to study orientation)
• History of asthma
• Experience recent (< 1 month of starting the study) cold, coughs, or respiratory tract infections
• Allergy to skin adhesive
• Known allergy to sulfa drugs
• Evidence of apnea or sleeping disorder
• Present condition of alcoholism, use of anabolic steroids, other substance abuse issues
• Inability to tolerate iron supplement

Where it is running

• USARIEM — Natick, Massachusetts, United States

Full record on ClinicalTrials.gov

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