Erythropoietin in the Prevention of Acute Mountain Sickness

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Brief Title

Erythropoietin in the Prevention of Acute Mountain Sickness

Official Title

Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness

Brief 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 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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Acute mountain sickness score

Secondary Outcome

 Criteria for immediate descent[USARIEM]

Condition

Acute Mountain Sickness

Intervention

Erythropoietin

Study Arms / Comparison Groups

 Erythropoietin
Description:  Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

August 2012

Completion Date

March 2013

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy adults

        Exclusion Criteria:

          -  History of serious illness

          -  Current smoker or Hemoglobin >15.5gm/dL

          -  Uncontrolled hypertension
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Soon Bae Kim, M.D., Ph.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01665781

Organization ID

AMCIRB2012-0534


Responsible Party

Principal Investigator

Study Sponsor

University of Ulsan

Collaborators

 CJ HealthCare Corporation

Study Sponsor

Soon Bae Kim, M.D., Ph.D., Principal Investigator, University of Ulsan


Verification Date

March 2013