Colorado-Oregon Altitude Study
- Conditions
- Acute Mountain Sickness
- Interventions
- Registration Number
- NCT05734716
- Lead Sponsor
- University of Oregon
- Brief Summary
Investigating the utility of prophylactic treatment with iron sucrose and/or erythropoietin on the prevention of acute mountain sickness in fit, young, healthy individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Ages 18 to 40
Recreational athletes able to pass the APFTs
Men and women of any ethnic background
Medical and dental insurance
Able to read and speak English
Fully vaccinated against COVID-19
- If a subject is taking medication that is deemed safe and will not interfere with the main outcome measurements of the study as determined by clinical research staff, they will be included.
- If a subject had a previous mild to moderate COVID-19 infection but is deemed safe for all research activities by clinical research staff, then they will be included in the study.
- Smokers
Previous severe COVID infection or contraction of any COVID infection occurring during the study. Previous mild to moderate COVID infections will be considered for the study on a case-by-case basis as determined safe by clinical research staff (see inclusion criteria).
Carboxyhemoglobin values (HbCO) 3% or greater at baseline
Diseases or disorders known to be affected by hypoxia or the drugs used in this study, including but not limited to hypotension, anemia, sickle cell trait or disease, and diabetes.
Anyone unable to receive the investigational drugs used in this protocol (EPO or iron).
Those with a history of significant head injury, migraines or seizures.
Anyone that is pregnant or trying to become pregnant.
Any medication determined by the clinical research staff to be unsafe or to interfere with the outcome measurements of the study.
Those with inability to be headache-free when consuming the amount of caffeine in two six-ounce cups of coffee or less per day.
Extended exposure (>6 hours) to high altitude above 1000m in the month leading up to departure to Colorado.
Those who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude) within the month leading up to departure to Colorado.
Those who are unable to achieve the minimum physical criteria as outlined above.
Anyone with lung function below the lower limit of normal per GLI standards.
Previous diagnosis of high altitude pulmonary edema or high altitude cerebral edema upon altitude exposure.
Failure to get fully vaccinated against COVID-19. Choosing not to be vaccinated will result in exclusion.
Family history of clotting disorders, anemia or venous thrombosis.
Plans for professional competition during or within 1 week after participation in this study as participation may enhance your aerobic performance
Presence or absence of a PFO once we have enrolled a sufficient number of each group representation in the general population (e.g., ~40% of population has a PFO and ~60% does not). However, all subjects will be allowed to complete all baseline screening to assure that we will have enough subjects to go to Colorado
Biological sex once we have enrolled a sufficient number of males and/or females as we are aiming to enroll ~50% of each sex. However, all subjects will be allowed to complete all baseline screening to assure that we will have enough subjects to go to Colorado.
Subjects will be excluded from telemetric pill ONLY if they have a history of obstructive diseases of the gastrointestinal tract including diverticulosis, diverticulitis, inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis, or previous GI surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPO Arm Erythropoietin participants administered subcutaneous erythropoietin injection (50 IU/kg 3x/week for 3 weeks) prior to ascent to altitutude. participants additionally administered sham intravenous treatment twice, with dosages occurring three weeks apart and final shame dose occurring 48 hours prior to ascent to altitude. Placebo Sterile Sodium Chloride participants administered sham injections (sterile saline) 3x/week for 3 weeks as well as sham intravenous infusion (sterile saline) twice with dosages occurring three weeks apart and final dosing occurring 48 hours prior to ascent to altitude. Iron Arm Iron sucrose (Venofer) participants administered intravenous iron sucrose (200mg) twice, dosages occurring three weeks apart with final dosing occurring 48 hours prior to ascent to altitude. Participants additionally administered sham subcutaneous injection (sterile saline) 3x/week for 3 weeks.
- Primary Outcome Measures
Name Time Method Hemoglobin Mass Day 13 of Altitude total mass of hemoglobin in body
five kilometer run time trial Day 13 of Altitude time to cover 5 kilometers
Lake Louise Score 24 hours after ascent to altitude Lake Louise Score of Acute Mountain Sickness symptoms
p50 Day 13 of Altitude oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
rucksack carry Day 14 of altitude time to complete rucksack (35 pounds) course
body core temperature during 5k time trial day 13 of Altitude body core temperature as measured by telemetric pill
pulmonary arterial systolic pressure day 13 ascent to altitude highest pressure experienced in pulmonary vasculature during cardiac cycle
hypercapnic ventilatory response Day 13 of Altitude level of end-tidal carbon dioxide which stimulates a ventilatory response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Colorado Mountain College
🇺🇸Leadville, Colorado, United States
Cardiopulmonary and Respiratory Physiology Lab
🇺🇸Eugene, Oregon, United States