Clinical Trial: A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent

Brief Summary:

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.


Detailed Summary:
Sponsor: Oxford University Clinical Research Unit, Vietnam

Current Primary Outcome:

  • Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
  • Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Percent
  • Heart rate [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Beats per minute
  • High altitude headache [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Percent
  • Heart rate [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Beats per minute
  • High altitude headache [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    High altitude headache severity will be scored in millimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.


Original Secondary Outcome:

  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Percent
  • Heart rate [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Beats per minute
  • High altitude headache [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Percent
  • Heart rate [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Beats per minute
  • High altitude headache [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.


Information By: Oxford University Clinical Research Unit, Vietnam

Dates:
Date Received: August 8, 2011
Date Started: August 2011
Date Completion:
Last Updated: June 21, 2013
Last Verified: June 2013