Colorado-Oregon Altitude Study (COAST)

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

Study Overview

• Status: Completed
• Conditions: Acute Mountain Sickness
• Intervention / Treatment: Drug: Erythropoietin; Drug: Iron sucrose (Venofer); Drug: Sterile Sodium Chloride

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Leadville, Colorado, United States, 80461
      • Colorado Mountain College
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Cardiopulmonary and Respiratory Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPO Arm; 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; use of erythropoietin to stimulate red blood cell development prior to ascent to altitude
Experimental: Iron Arm; 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); use of iron sucrose to stimulate red blood cell development prior to ascent to altitude
Placebo Comparator: Placebo; 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; sham treatment with sterile saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness; Hematinics; Epoetin Alfa; Ferric Oxide, Saccharated
• Other Study ID Numbers: STUDY00000019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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