Acute Mountain SicknessPhase 4EPO-AMSNCT01665781
Erythropoietin in the Prevention of Acute Mountain Sickness
A Phase 4 study testing Erythropoietin in people with Acute Mountain Sickness, run by University of Ulsan at 1 site in South Korea.
Trial summary
Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Mar 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- History of serious illness
- Current smoker or Hemoglobin >15.5gm/dL
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.
In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.
Read more
However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.
The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.
In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.
- Conditions
- Acute Mountain Sickness
- Being tested
- Erythropoietin
- Keywords
- Hemoglobin, Erythropoietin, Acute Mountain sickness
- 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
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude) Receives: Drug: Erythropoietin |
| Control | No intervention | No erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute mountain sickness score
The AMS self-report score is the sum of answers to five questions (headache; gastrointestinal symptoms (anorexia, nausea, or vomiting); fatigue or weakness; dizziness or lightheadedness; difficulty sleeping) rating from 0 to 3.
Measured: At 3230m and 4,130m(Annapurna base camp)
Secondary outcomes (1)
Criteria for immediate descent[USARIEM]
- High altitude cerebral edema 1) Mental confusion 2) Ataxia 3) Severe lassitude
- Moderate high altitude pulmonary edema 1) Symptoms of dyspnea, weakness, fatigue with mild exertion 2) Cannot perform light activity 3) Headache with cough, dyspnea at rest 4) Heartbeats per min: 110-120 5) Breaths per min: 20-30
- Severe AMS: LLS >8
Measured: At 3230m and 4,130m(Annapurna base camp)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulsan
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Principal investigator, Soon Bae Kim, M.D., PhD., University of Ulsan
- Investigators
- Soon Bae Kim, M.D., Ph.D., Principal investigator, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665781
- Sponsor's protocol ID
- AMCIRB2012-0534
- Acronym
- EPO-AMS
- Status last verified
- Mar 2013
- First submitted
- 12 Aug 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heo K, Kang JK, Choi CM, Lee MS, Noh KW, Kim SB. Prophylactic effect of erythropoietin injection to prevent acute mountain sickness: an open-label randomized controlled trial. J Korean Med Sci. 2014 Mar;29(3):416-22. doi: 10.3346/jkms.2014.29.3.416. Epub 2014 Feb 27.
PubMed 24616593
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
- ClinicalTrials.gov ID
- NCT01665781
- Acronym / sponsor ID
- EPO-AMS / AMCIRB2012-0534
- Conditions
- Acute Mountain Sickness
- Keywords
- Hemoglobin, Erythropoietin, Acute Mountain sickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of UlsanUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Aug 2012 (estimated)
- 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.
Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.
In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.
However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.
The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.
In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: ErythropoietinErythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude) |
| Control | No intervention | –No erythropoietin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (3 listed)
- History of serious illness
- Current smoker or Hemoglobin >15.5gm/dL
- Uncontrolled hypertension
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 |
|---|---|---|
| Erythropoietin | Drug | Erythropoietin |
Primary outcome
Acute mountain sickness score
Time frame: At 3230m and 4,130m(Annapurna base camp)
The AMS self-report score is the sum of answers to five questions (headache; gastrointestinal symptoms (anorexia, nausea, or vomiting); fatigue or weakness; dizziness or lightheadedness; difficulty sleeping) rating from 0 to 3.
1 secondary outcome
Criteria for immediate descent[USARIEM]
Time frame: At 3230m and 4,130m(Annapurna base camp)
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 19 Mar 2013.
- Derived from this study: PubMed 24616593Heo K, Kang JK, Choi CM, Lee MS, Noh KW, Kim SB. Prophylactic effect of erythropoietin injection to prevent acute mountain sickness: an open-label randomized controlled trial. J Korean Med Sci. 2014 Mar;29(3):416-22. doi: 10.3346/jkms.2014.29.3.416. Epub 2014 Feb 27.
Related trials for Acute Mountain Sickness
Recruiting
Erythrocytapheresis for Chronic Mountain Sickness
Chronic Mountain Sickness
Not yet recruitingPhase 4
Calcitonin Gene-related Peptide Antibody in Acute Mountain Sickness
Acute Mountain Sickness
Not yet recruiting
Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application
Severe High Altitude Pulmonary Edema, Severe High Altitude Cerebral Edema
RecruitingObservational study
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia
Recruiting
Effect of Acute Hypoxia on RIght VEntRicular Function in Asthma.
Hypoxia, Altitude, Hypoxia
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.
Soon Bae Kim, M.D., Ph.D. principal investigator
University of Ulsan
1 site 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 in people with Acute Mountain Sickness, run by University of Ulsan at 1 site in South Korea.
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 1 inclusion and 3 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 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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?
Acute mountain sickness score (time frame: At 3230m and 4,130m(Annapurna base camp)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665781, which also lists 1 linked publication.
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 19 Mar 2013.