Colorado-Oregon Altitude Study

Study Overview
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Brief Summary
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Investigating the utility of prophylactic treatment with iron sucrose and/or erythropoietin on the prevention of acute mountain sickness in fit, young, healthy individuals.

Official Title
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Colorado-Oregon Altitude Study

Conditions
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Acute Mountain Sickness

Intervention / Treatment
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* Drug: Erythropoietin
* Drug: Iron sucrose (Venofer)
* Drug: Sterile Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPO Arm<br>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. | Drug: Erythropoietin<br>* use of erythropoietin to stimulate red blood cell development prior to ascent to altitude<br>|
| Experimental: Iron Arm<br>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. | Drug: Iron sucrose (Venofer)<br>* use of iron sucrose to stimulate red blood cell development prior to ascent to altitude<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Sterile Sodium Chloride<br>* sham treatment with sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lake Louise Score | Lake Louise Score of Acute Mountain Sickness symptoms | Pre-ascension to altitude | 
| Lake Louise Score | Lake Louise Score of Acute Mountain Sickness symptoms | Day 1 ascent to altitude | 
| Lake Louise Score | Lake Louise Score of Acute Mountain Sickness symptoms | 24 hours after ascent to altitude | 
| Hemoglobin Mass | total mass of hemoglobin in body | Pre-ascent to altitude | 
| Hemoglobin Mass | total mass of hemoglobin in body | Day 1 of Altitude | 
| Hemoglobin Mass | total mass of hemoglobin in body | Day 7 of Altitude | 
| Hemoglobin Mass | total mass of hemoglobin in body | Day 13 of Altitude | 
| five kilometer run time trial | time to cover 5 kilometers | Pre-ascension to altitude | 
| five kilometer run time trial | time to cover 5 kilometers | Day 1 of Altitude | 
| five kilometer run time trial | time to cover 5 kilometers | Day 7 of Altitude | 
| five kilometer run time trial | time to cover 5 kilometers | Day 13 of Altitude | 
| p50 | oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen | Pre-ascension to altitude | 
| p50 | oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen | Day 1 of Altitude | 
| p50 | oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen | Day 7 of Altitude | 
| p50 | oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen | Day 13 of Altitude | 
| rucksack carry | time to complete rucksack (35 pounds) course | Pre-ascent to altitude | 
| rucksack carry | time to complete rucksack (35 pounds) course | Day 2 of altitude | 
| rucksack carry | time to complete rucksack (35 pounds) course | Day 14 of altitude | 
| pulmonary arterial systolic pressure | highest pressure experienced in pulmonary vasculature during cardiac cycle | Pre-ascent to altitude | 
| pulmonary arterial systolic pressure | highest pressure experienced in pulmonary vasculature during cardiac cycle | day 1 ascent to altitude | 
| pulmonary arterial systolic pressure | highest pressure experienced in pulmonary vasculature during cardiac cycle | day 7 ascent to altitude | 
| pulmonary arterial systolic pressure | highest pressure experienced in pulmonary vasculature during cardiac cycle | day 13 ascent to altitude | 
| hypercapnic ventilatory response | level of end-tidal carbon dioxide which stimulates a ventilatory response | Pre-ascent to altitude | 
| hypercapnic ventilatory response | level of end-tidal carbon dioxide which stimulates a ventilatory response | Day 1 of Altitude | 
| hypercapnic ventilatory response | level of end-tidal carbon dioxide which stimulates a ventilatory response | Day 7 of Altitude | 
| hypercapnic ventilatory response | level of end-tidal carbon dioxide which stimulates a ventilatory response | Day 13 of Altitude | 
| body core temperature | body core temperature as measured by telemetric pill | during 5k time trial pre-ascent to altitude | 
| body core temperature | body core temperature as measured by telemetric pill | during 5k time trial day 1 of Altitude | 
| body core temperature | body core temperature as measured by telemetric pill | during 5k time trial day 7 of Altitude | 
| body core temperature | body core temperature as measured by telemetric pill | during 5k time trial day 13 of Altitude |