Pharmacological Countermeasures for High Altitude

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Army Research Institute of Environmental Medicine
• Collaborator: University of Puget Sound
• Treatments: Acetazolamide; Epoetin Alfa

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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