Pharmacological Countermeasures for High Altitude

This is an interventional other trial for Hypobaric Hypoxia Read More

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