Colorado-Oregon Altitude Study

Acute Mountain Sickness Clinical Trial

— COAST  

Official title:

Colorado-Oregon Altitude Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734716
• Other study ID #: STUDY00000019
• Status: Completed
• Phase: Phase 4
• Start date: February 17, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Drug:
• Erythropoietin
use of erythropoietin to stimulate red blood cell development prior to ascent to altitude
• Iron sucrose (Venofer)
use of iron sucrose to stimulate red blood cell development prior to ascent to altitude
• Sterile Sodium Chloride
sham treatment with sterile saline

Locations

Country	Name	City	State
United States	Cardiopulmonary and Respiratory Physiology Lab	Eugene	Oregon
United States	Colorado Mountain College	Leadville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

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