Acute Mountain Sickness Clinical Trial
Official title:
Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent
Acute mountain sickness is a common ailment in people venturing over 2500 m altitude.
Pilgrims to high altitudes are at an added risk since they are unaware and they gain height
faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of
acute mountain sickness. There are no randomized controlled trials that have studied
protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies
regarding this matter.
This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus
placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent
that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo
will be randomly assigned for 3 days and participants will be assessed at 3 stations.
This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be
the first RCT done in this issue.
The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent
to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the
incidence and severity of acute mountain sickness.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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