Status:
ACTIVE_NOT_RECRUITING
Pharmacological Countermeasures for High Altitude
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
University of Puget Sound
Conditions:
Hypobaric Hypoxia
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief 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...
Detailed Description
This study will use a double-blind randomized study design in which one group will receive erythropoietin and the other a placebo (saline) for 4 weeks, then both groups will receive acetazolamide. Eig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05300477
Start Date
May 27 2022
End Date
September 30 2025
Last Update
March 26 2025
Active Locations (1)
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1
USARIEM
Natick, Massachusetts, United States, 01760