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Erythropoietin in the Prevention of Acute Mountain Sickness (EPO-AMS)

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ClinicalTrials.gov Identifier: NCT01665781
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : March 19, 2013
HK inno.N Corporation
Information provided by (Responsible Party):
Soon Bae Kim, M.D., PhD., University of Ulsan

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.

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: Erythropoietin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Study Start Date : August 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Erythropoietin
Erythropoietin 10,000U, weekly, for 4 weeks Last dose: 1 week before departure (10days before high altitude)
Drug: Erythropoietin
No Intervention: Control
No erythropoietin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Criteria for immediate descent[USARIEM] [ Time Frame: At 3230m and 4,130m(Annapurna base camp) ]
    1. High altitude cerebral edema 1) Mental confusion 2) Ataxia 3) Severe lassitude
    2. 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
    3. Severe AMS: LLS >8

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • History of serious illness
  • Current smoker or Hemoglobin >15.5gm/dL
  • Uncontrolled hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665781

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Korea, Republic of
Soon Bae Kim, M.D., Ph.D.
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
University of Ulsan
HK inno.N Corporation
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Principal Investigator: Soon Bae Kim, M.D., Ph.D. University of Ulsan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Soon Bae Kim, M.D., PhD., Professor of Medicine, University of Ulsan
ClinicalTrials.gov Identifier: NCT01665781    
Other Study ID Numbers: AMCIRB2012-0534
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
Keywords provided by Soon Bae Kim, M.D., PhD., University of Ulsan:
Acute Mountain sickness
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Epoetin Alfa