Skip to main content
OpenTrials
Completed

NCT Number: NCT05734716

Colorado-Oregon Altitude Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Mountain Sickness Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Colorado Mountain College, Leadville, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythropoietin

Drug

use of erythropoietin to stimulate red blood cell development prior to ascent to altitude

Iron Sucrose (Venofer)

Drug

use of iron sucrose to stimulate red blood cell development prior to ascent to altitude

Sterile Sodium Chloride

Drug

sham treatment with sterile saline

Primary outcomes

  1. Lake Louise Score

    Time frame: Pre-ascension to altitude

    Lake Louise Score of Acute Mountain Sickness symptoms

  2. Lake Louise Score

    Time frame: Day 1 ascent to altitude

    Lake Louise Score of Acute Mountain Sickness symptoms

  3. Lake Louise Score

    Time frame: 24 hours after ascent to altitude

    Lake Louise Score of Acute Mountain Sickness symptoms

  4. Hemoglobin Mass

    Time frame: Pre-ascent to altitude

    total mass of hemoglobin in body

  5. Hemoglobin Mass

    Time frame: Day 1 of Altitude

    total mass of hemoglobin in body

  6. Hemoglobin Mass

    Time frame: Day 7 of Altitude

    total mass of hemoglobin in body

  7. Hemoglobin Mass

    Time frame: Day 13 of Altitude

    total mass of hemoglobin in body

  8. five kilometer run time trial

    Time frame: Pre-ascension to altitude

    time to cover 5 kilometers

  9. five kilometer run time trial

    Time frame: Day 1 of Altitude

    time to cover 5 kilometers

  10. five kilometer run time trial

    Time frame: Day 7 of Altitude

    time to cover 5 kilometers

  11. five kilometer run time trial

    Time frame: Day 13 of Altitude

    time to cover 5 kilometers

  12. p50

    Time frame: Pre-ascension to altitude

    oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  13. p50

    Time frame: Day 1 of Altitude

    oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  14. p50

    Time frame: Day 7 of Altitude

    oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  15. p50

    Time frame: Day 13 of Altitude

    oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  16. rucksack carry

    Time frame: Pre-ascent to altitude

    time to complete rucksack (35 pounds) course

  17. rucksack carry

    Time frame: Day 2 of altitude

    time to complete rucksack (35 pounds) course

  18. rucksack carry

    Time frame: Day 14 of altitude

    time to complete rucksack (35 pounds) course

  19. pulmonary arterial systolic pressure

    Time frame: Pre-ascent to altitude

    highest pressure experienced in pulmonary vasculature during cardiac cycle

  20. pulmonary arterial systolic pressure

    Time frame: day 1 ascent to altitude

    highest pressure experienced in pulmonary vasculature during cardiac cycle

  21. pulmonary arterial systolic pressure

    Time frame: day 7 ascent to altitude

    highest pressure experienced in pulmonary vasculature during cardiac cycle

  22. pulmonary arterial systolic pressure

    Time frame: day 13 ascent to altitude

    highest pressure experienced in pulmonary vasculature during cardiac cycle

  23. hypercapnic ventilatory response

    Time frame: Pre-ascent to altitude

    level of end-tidal carbon dioxide which stimulates a ventilatory response

  24. hypercapnic ventilatory response

    Time frame: Day 1 of Altitude

    level of end-tidal carbon dioxide which stimulates a ventilatory response

  25. hypercapnic ventilatory response

    Time frame: Day 7 of Altitude

    level of end-tidal carbon dioxide which stimulates a ventilatory response

  26. hypercapnic ventilatory response

    Time frame: Day 13 of Altitude

    level of end-tidal carbon dioxide which stimulates a ventilatory response

  27. body core temperature

    Time frame: during 5k time trial pre-ascent to altitude

    body core temperature as measured by telemetric pill

  28. body core temperature

    Time frame: during 5k time trial day 1 of Altitude

    body core temperature as measured by telemetric pill

  29. body core temperature

    Time frame: during 5k time trial day 7 of Altitude

    body core temperature as measured by telemetric pill

  30. body core temperature

    Time frame: during 5k time trial day 13 of Altitude

    body core temperature as measured by telemetric pill

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Acronym: COAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.