Colorado-Oregon Altitude Study (COAST)

March 8, 2023 updated by: University of Oregon
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lake Louise Score
Time Frame: Pre-ascension to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
Pre-ascension to altitude
Lake Louise Score
Time Frame: Day 1 ascent to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
Day 1 ascent to altitude
Lake Louise Score
Time Frame: 24 hours after ascent to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
24 hours after ascent to altitude
Hemoglobin Mass
Time Frame: Pre-ascent to altitude
total mass of hemoglobin in body
Pre-ascent to altitude
Hemoglobin Mass
Time Frame: Day 1 of Altitude
total mass of hemoglobin in body
Day 1 of Altitude
Hemoglobin Mass
Time Frame: Day 7 of Altitude
total mass of hemoglobin in body
Day 7 of Altitude
Hemoglobin Mass
Time Frame: Day 13 of Altitude
total mass of hemoglobin in body
Day 13 of Altitude
five kilometer run time trial
Time Frame: Pre-ascension to altitude
time to cover 5 kilometers
Pre-ascension to altitude
five kilometer run time trial
Time Frame: Day 1 of Altitude
time to cover 5 kilometers
Day 1 of Altitude
five kilometer run time trial
Time Frame: Day 7 of Altitude
time to cover 5 kilometers
Day 7 of Altitude
five kilometer run time trial
Time Frame: Day 13 of Altitude
time to cover 5 kilometers
Day 13 of Altitude
p50
Time Frame: Pre-ascension to altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Pre-ascension to altitude
p50
Time Frame: Day 1 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Day 1 of Altitude
p50
Time Frame: Day 7 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Day 7 of Altitude
p50
Time Frame: Day 13 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Day 13 of Altitude
rucksack carry
Time Frame: Pre-ascent to altitude
time to complete rucksack (35 pounds) course
Pre-ascent to altitude
rucksack carry
Time Frame: Day 2 of altitude
time to complete rucksack (35 pounds) course
Day 2 of altitude
rucksack carry
Time Frame: Day 14 of altitude
time to complete rucksack (35 pounds) course
Day 14 of altitude
pulmonary arterial systolic pressure
Time Frame: Pre-ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
Pre-ascent to altitude
pulmonary arterial systolic pressure
Time Frame: day 1 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
day 1 ascent to altitude
pulmonary arterial systolic pressure
Time Frame: day 7 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
day 7 ascent to altitude
pulmonary arterial systolic pressure
Time Frame: day 13 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
day 13 ascent to altitude
hypercapnic ventilatory response
Time Frame: Pre-ascent to altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
Pre-ascent to altitude
hypercapnic ventilatory response
Time Frame: Day 1 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
Day 1 of Altitude
hypercapnic ventilatory response
Time Frame: Day 7 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
Day 7 of Altitude
hypercapnic ventilatory response
Time Frame: Day 13 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
Day 13 of Altitude
body core temperature
Time Frame: during 5k time trial pre-ascent to altitude
body core temperature as measured by telemetric pill
during 5k time trial pre-ascent to altitude
body core temperature
Time Frame: during 5k time trial day 1 of Altitude
body core temperature as measured by telemetric pill
during 5k time trial day 1 of Altitude
body core temperature
Time Frame: during 5k time trial day 7 of Altitude
body core temperature as measured by telemetric pill
during 5k time trial day 7 of Altitude
body core temperature
Time Frame: during 5k time trial day 13 of Altitude
body core temperature as measured by telemetric pill
during 5k time trial day 13 of Altitude

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings