Acute Mountain SicknessPhase 4COASTNCT05734716
Colorado-Oregon Altitude Study
A Phase 4 study testing Erythropoietin, Iron sucrose (Venofer) and Sterile Sodium Chloride in people with Acute Mountain Sickness, run by University of Oregon at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Erythropoietin, Iron sucrose (Venofer) and Sterile Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2021to 1 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiopulmonary and Respiratory Physiology Lab
Eugene, Oregon, 97403
Colorado Mountain College
Leadville, Colorado, 80461
About this 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.
- Conditions
- Acute Mountain Sickness
- Being tested
- Erythropoietin, Iron sucrose (Venofer), Sterile Sodium Chloride
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
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 ChlorideDrug
sham treatment with sterile saline
| Study group | Role | What they receive |
|---|---|---|
| EPO Arm | Experimental | 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. Receives: Drug: Erythropoietin |
| Iron Arm | Experimental | 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. Receives: Drug: Iron sucrose (Venofer) |
| Placebo | Placebo comparator | 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. Receives: Drug: Sterile Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Measured: Pre-ascension to altitude
Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Measured: Day 1 ascent to altitude
Lake Louise Score
Lake Louise Score of Acute Mountain Sickness symptoms
Measured: 24 hours after ascent to altitude
Hemoglobin Mass
total mass of hemoglobin in body
Measured: Pre-ascent to altitude
Hemoglobin Mass
total mass of hemoglobin in body
Measured: Day 1 of Altitude
Hemoglobin Mass
total mass of hemoglobin in body
Measured: Day 7 of Altitude
Hemoglobin Mass
total mass of hemoglobin in body
Measured: Day 13 of Altitude
five kilometer run time trial
time to cover 5 kilometers
Measured: Pre-ascension to altitude
five kilometer run time trial
time to cover 5 kilometers
Measured: Day 1 of Altitude
five kilometer run time trial
time to cover 5 kilometers
Measured: Day 7 of Altitude
five kilometer run time trial
time to cover 5 kilometers
Measured: Day 13 of Altitude
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Measured: Pre-ascension to altitude
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Measured: Day 1 of Altitude
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Measured: Day 7 of Altitude
p50
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
Measured: Day 13 of Altitude
rucksack carry
time to complete rucksack (35 pounds) course
Measured: Pre-ascent to altitude
rucksack carry
time to complete rucksack (35 pounds) course
Measured: Day 2 of altitude
rucksack carry
time to complete rucksack (35 pounds) course
Measured: Day 14 of altitude
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
Measured: Pre-ascent to altitude
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
Measured: day 1 ascent to altitude
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
Measured: day 7 ascent to altitude
pulmonary arterial systolic pressure
highest pressure experienced in pulmonary vasculature during cardiac cycle
Measured: day 13 ascent to altitude
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
Measured: Pre-ascent to altitude
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
Measured: Day 1 of Altitude
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
Measured: Day 7 of Altitude
hypercapnic ventilatory response
level of end-tidal carbon dioxide which stimulates a ventilatory response
Measured: Day 13 of Altitude
body core temperature
body core temperature as measured by telemetric pill
Measured: during 5k time trial pre-ascent to altitude
body core temperature
body core temperature as measured by telemetric pill
Measured: during 5k time trial day 1 of Altitude
body core temperature
body core temperature as measured by telemetric pill
Measured: during 5k time trial day 7 of Altitude
body core temperature
body core temperature as measured by telemetric pill
Measured: during 5k time trial day 13 of Altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 Feb 2021
- Primary completion1 Aug 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734716
- Sponsor's protocol ID
- STUDY00000019
- Acronym
- COAST
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorado-Oregon Altitude Study
- ClinicalTrials.gov ID
- NCT05734716
- Acronym / sponsor ID
- COAST / STUDY00000019
- Conditions
- Acute Mountain Sickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPO Arm | Experimental | Drug: Erythropoietinparticipants 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. |
| Iron Arm | Experimental | Drug: Iron sucrose (Venofer)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. |
| Placebo | Placebo comparator | Drug: Sterile Sodium Chlorideparticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoietinuse of erythropoietin to stimulate red blood cell development prior to ascent to altitude | Drug | EPO Arm |
| Iron sucrose (Venofer)use of iron sucrose to stimulate red blood cell development prior to ascent to altitude | Drug | Iron Arm |
| Sterile Sodium Chloridesham treatment with sterile saline | Drug | Placebo |
Primary outcome
Lake Louise Score
Time frame: Pre-ascension to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
Lake Louise Score
Time frame: Day 1 ascent to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
Lake Louise Score
Time frame: 24 hours after ascent to altitude
Lake Louise Score of Acute Mountain Sickness symptoms
Hemoglobin Mass
Time frame: Pre-ascent to altitude
total mass of hemoglobin in body
Hemoglobin Mass
Time frame: Day 1 of Altitude
total mass of hemoglobin in body
Hemoglobin Mass
Time frame: Day 7 of Altitude
total mass of hemoglobin in body
Hemoglobin Mass
Time frame: Day 13 of Altitude
total mass of hemoglobin in body
five kilometer run time trial
Time frame: Pre-ascension to altitude
time to cover 5 kilometers
five kilometer run time trial
Time frame: Day 1 of Altitude
time to cover 5 kilometers
five kilometer run time trial
Time frame: Day 7 of Altitude
time to cover 5 kilometers
five kilometer run time trial
Time frame: Day 13 of Altitude
time to cover 5 kilometers
p50
Time frame: Pre-ascension to altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
Time frame: Day 1 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
Time frame: Day 7 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
p50
Time frame: Day 13 of Altitude
oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen
rucksack carry
Time frame: Pre-ascent to altitude
time to complete rucksack (35 pounds) course
rucksack carry
Time frame: Day 2 of altitude
time to complete rucksack (35 pounds) course
rucksack carry
Time frame: Day 14 of altitude
time to complete rucksack (35 pounds) course
pulmonary arterial systolic pressure
Time frame: Pre-ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
Time frame: day 1 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
Time frame: day 7 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
pulmonary arterial systolic pressure
Time frame: day 13 ascent to altitude
highest pressure experienced in pulmonary vasculature during cardiac cycle
hypercapnic ventilatory response
Time frame: Pre-ascent to altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
Time frame: Day 1 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
Time frame: Day 7 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
hypercapnic ventilatory response
Time frame: Day 13 of Altitude
level of end-tidal carbon dioxide which stimulates a ventilatory response
body core temperature
Time frame: during 5k time trial pre-ascent to altitude
body core temperature as measured by telemetric pill
body core temperature
Time frame: during 5k time trial day 1 of Altitude
body core temperature as measured by telemetric pill
body core temperature
Time frame: during 5k time trial day 7 of Altitude
body core temperature as measured by telemetric pill
body core temperature
Time frame: during 5k time trial day 13 of Altitude
body core temperature as measured by telemetric pill
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythropoietin, Iron sucrose (Venofer) and Sterile Sodium Chloride in people with Acute Mountain Sickness, run by University of Oregon at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lake Louise Score (time frame: Pre-ascension to altitude). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.