Clinical trial NCT01665781: Erythropoietin in the Prevention of Acute Mountain Sickness
Official title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Mountain Sickness
Keywords: Hemoglobin
Erythropoietin
Acute Mountain sickness
Lead sponsor: University of Ulsan
Sponsor class: OTHER
Collaborators: name: HK inno.N Corporation
First posted: 2012-08-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

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

Primary outcomes:
measure: Acute mountain sickness score
timeFrame: At 3230m and 4,130m(Annapurna base camp)
Secondary outcomes:
measure: Criteria for immediate descent[USARIEM]
timeFrame: At 3230m and 4,130m(Annapurna base camp)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Bae Kim, M.D., Ph.D.
Study officials:
affiliation: University of Ulsan
name: Soon Bae Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.