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Colorado-Oregon Altitude Study (COAST)

Primary Purpose

Acute Mountain Sickness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Erythropoietin
Iron sucrose (Venofer)
Sterile Sodium Chloride
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Mountain Sickness

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Colorado Mountain College
  • Cardiopulmonary and Respiratory Physiology Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EPO Arm

Iron Arm

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Hemoglobin Mass
total mass of hemoglobin in body
Hemoglobin Mass
total mass of hemoglobin in body
Hemoglobin Mass
total mass of hemoglobin in body
Hemoglobin Mass
total mass of hemoglobin in body
five kilometer run time trial
time to cover 5 kilometers
five kilometer run time trial
time to cover 5 kilometers
five kilometer run time trial
time to cover 5 kilometers
five kilometer run time trial
time to cover 5 kilometers
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
rucksack carry
time to complete rucksack (35 pounds) course
rucksack carry
time to complete rucksack (35 pounds) course
rucksack carry
time to complete rucksack (35 pounds) course
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
body core temperature
body core temperature as measured by telemetric pill
body core temperature
body core temperature as measured by telemetric pill
body core temperature
body core temperature as measured by telemetric pill
body core temperature
body core temperature as measured by telemetric pill

Secondary Outcome Measures

Full Information

First Posted
January 30, 2023
Last Updated
March 8, 2023
Sponsor
University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT05734716
Brief Title
Colorado-Oregon Altitude Study
Acronym
COAST
Official Title
Colorado-Oregon Altitude Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants and researchers involved in data collection are blinded to the treatment assignment of all participants.
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Iron Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Intervention Description
use of erythropoietin to stimulate red blood cell development prior to ascent to altitude
Intervention Type
Drug
Intervention Name(s)
Iron sucrose (Venofer)
Intervention Description
use of iron sucrose to stimulate red blood cell development prior to ascent to altitude
Intervention Type
Drug
Intervention Name(s)
Sterile Sodium Chloride
Intervention Description
sham treatment with sterile saline
Primary Outcome Measure Information:
Title
Lake Louise Score
Description
Lake Louise Score of Acute Mountain Sickness symptoms
Time Frame
Pre-ascension to altitude
Title
Lake Louise Score
Description
Lake Louise Score of Acute Mountain Sickness symptoms
Time Frame
Day 1 ascent to altitude
Title
Lake Louise Score
Description
Lake Louise Score of Acute Mountain Sickness symptoms
Time Frame
24 hours after ascent to altitude
Title
Hemoglobin Mass
Description
total mass of hemoglobin in body
Time Frame
Pre-ascent to altitude
Title
Hemoglobin Mass
Description
total mass of hemoglobin in body
Time Frame
Day 1 of Altitude
Title
Hemoglobin Mass
Description
total mass of hemoglobin in body
Time Frame
Day 7 of Altitude
Title
Hemoglobin Mass
Description
total mass of hemoglobin in body
Time Frame
Day 13 of Altitude
Title
five kilometer run time trial
Description
time to cover 5 kilometers
Time Frame
Pre-ascension to altitude
Title
five kilometer run time trial
Description
time to cover 5 kilometers
Time Frame
Day 1 of Altitude
Title
five kilometer run time trial
Description
time to cover 5 kilometers
Time Frame
Day 7 of Altitude
Title
five kilometer run time trial
Description
time to cover 5 kilometers
Time Frame
Day 13 of Altitude
Title
p50
Description
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Time Frame
Pre-ascension to altitude
Title
p50
Description
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Time Frame
Day 1 of Altitude
Title
p50
Description
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Time Frame
Day 7 of Altitude
Title
p50
Description
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Time Frame
Day 13 of Altitude
Title
rucksack carry
Description
time to complete rucksack (35 pounds) course
Time Frame
Pre-ascent to altitude
Title
rucksack carry
Description
time to complete rucksack (35 pounds) course
Time Frame
Day 2 of altitude
Title
rucksack carry
Description
time to complete rucksack (35 pounds) course
Time Frame
Day 14 of altitude
Title
pulmonary arterial systolic pressure
Description
highest pressure experienced in pulmonary vasculature during cardiac cycle
Time Frame
Pre-ascent to altitude
Title
pulmonary arterial systolic pressure
Description
highest pressure experienced in pulmonary vasculature during cardiac cycle
Time Frame
day 1 ascent to altitude
Title
pulmonary arterial systolic pressure
Description
highest pressure experienced in pulmonary vasculature during cardiac cycle
Time Frame
day 7 ascent to altitude
Title
pulmonary arterial systolic pressure
Description
highest pressure experienced in pulmonary vasculature during cardiac cycle
Time Frame
day 13 ascent to altitude
Title
hypercapnic ventilatory response
Description
level of end-tidal carbon dioxide which stimulates a ventilatory response
Time Frame
Pre-ascent to altitude
Title
hypercapnic ventilatory response
Description
level of end-tidal carbon dioxide which stimulates a ventilatory response
Time Frame
Day 1 of Altitude
Title
hypercapnic ventilatory response
Description
level of end-tidal carbon dioxide which stimulates a ventilatory response
Time Frame
Day 7 of Altitude
Title
hypercapnic ventilatory response
Description
level of end-tidal carbon dioxide which stimulates a ventilatory response
Time Frame
Day 13 of Altitude
Title
body core temperature
Description
body core temperature as measured by telemetric pill
Time Frame
during 5k time trial pre-ascent to altitude
Title
body core temperature
Description
body core temperature as measured by telemetric pill
Time Frame
during 5k time trial day 1 of Altitude
Title
body core temperature
Description
body core temperature as measured by telemetric pill
Time Frame
during 5k time trial day 7 of Altitude
Title
body core temperature
Description
body core temperature as measured by telemetric pill
Time Frame
during 5k time trial day 13 of Altitude

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Colorado Mountain College
City
Leadville
State/Province
Colorado
ZIP/Postal Code
80461
Country
United States
Facility Name
Cardiopulmonary and Respiratory Physiology Lab
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Colorado-Oregon Altitude Study

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