<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665781</url>
  </required_header>
  <id_info>
    <org_study_id>AMCIRB2012-0534</org_study_id>
    <nct_id>NCT01665781</nct_id>
  </id_info>
  <brief_title>Erythropoietin in the Prevention of Acute Mountain Sickness</brief_title>
  <acronym>EPO-AMS</acronym>
  <official_title>Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulsan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulsan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore&#xD;
      subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence&#xD;
      of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m&#xD;
      plus the presence of one or more of the following: gastrointestinal symptoms (anorexia,&#xD;
      nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass&#xD;
      is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO)&#xD;
      secretion begins hours after ascent and stimulates bone marrow production of red blood cells,&#xD;
      but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that&#xD;
      EPO therapy weeks before altitude exposure decrease high altitude illness.&#xD;
&#xD;
      In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM)&#xD;
      reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal&#xD;
      oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the&#xD;
      basis of this report, USARIEM did not recommend use of recombinant EPO for altitude&#xD;
      acclimatization.&#xD;
&#xD;
      However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO&#xD;
      therapy have been shown to decrease fatigue and increase work capacity and exercise&#xD;
      tolerance. In addition, improvement in CNS function and cognitive ability has been noted with&#xD;
      EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold;&#xD;
      decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are&#xD;
      symptoms associated with high altitude illness.&#xD;
&#xD;
      The investigators also reported improved muscle energy metabolism with EPO in dialysis&#xD;
      patients, but not with RBC transfusion.&#xD;
&#xD;
      In this study, the investigators will conduct a randomised controlled trial to assess the&#xD;
      effect of EPO administration on AMS at an altitude of 4,130 m.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute mountain sickness score</measure>
    <time_frame>At 3230m and 4,130m(Annapurna base camp)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Criteria for immediate descent[USARIEM]</measure>
    <time_frame>At 3230m and 4,130m(Annapurna base camp)</time_frame>
    <description>High altitude cerebral edema 1) Mental confusion 2) Ataxia 3) Severe lassitude&#xD;
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&#xD;
Severe AMS: LLS &gt;8</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Acute Mountain Sickness</condition>
  <arm_group>
    <arm_group_label>Erythropoietin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No erythropoietin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythropoietin</intervention_name>
    <arm_group_label>Erythropoietin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious illness&#xD;
&#xD;
          -  Current smoker or Hemoglobin &gt;15.5gm/dL&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soon Bae Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulsan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soon Bae Kim, M.D., Ph.D.</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>March 16, 2013</last_update_submitted>
  <last_update_submitted_qc>March 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulsan</investigator_affiliation>
    <investigator_full_name>Soon Bae Kim, M.D., PhD.</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Hemoglobin</keyword>
  <keyword>Erythropoietin</keyword>
  <keyword>Acute Mountain sickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665781
org study id: AMCIRB2012-0534
nct id: NCT01665781
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Acute mountain sickness score
time frame: At 3230m and 4,130m(Annapurna base camp)
description: 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.
measure: Criteria for immediate descent[USARIEM]
time frame: At 3230m and 4,130m(Annapurna base camp)
description: 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
arm group label: Erythropoietin
arm group type: Experimental
description: Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)
arm group label: Control
arm group type: No Intervention
description: No erythropoietin
intervention type: Drug
intervention name: Erythropoietin
arm group label: Erythropoietin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soon Bae Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Ulsan
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Ulsan
investigator full name: Soon Bae Kim, M.D., PhD.
investigator title: Professor of Medicine
mesh term: Altitude Sickness
mesh term: Epoetin Alfa