Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
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|ClinicalTrials.gov Identifier: NCT01993667|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prophylaxis of Acute Mountain Sickness||Drug: Low Dose Acetazolamide Drug: Normal Dose Acetazolamide||Phase 4|
Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude illness. The medication is effective in preventing acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude disorders.
Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending in elevation. Side effects include tingling of the fingers and toes and perioral numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild diuretic, frequent micturition may occur leading to interruption of daytime activities as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is normally discontinued 2 days after the user has reached their highest elevation or a plateau in elevation.
A lower dose may be just as effective in preventing high altitude illnesses while preventing the disconcerting side effects resulting from its use. A smaller dose has not been studied, however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg twice daily.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: Acetazolamide normal dose
Experimental : Acetazolamide 125 mg twice daily
Drug: Normal Dose Acetazolamide
Administration of normal dose acetazolamide
Other Name: Diamox
Experimental: Acetazolamide low dose
Experimental: Acetazolamide 62.5 mg twice daily
Drug: Low Dose Acetazolamide
Administration of low dose acetazolamide
Other Name: Diamox
- Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score [ Time Frame: 12 days ]Lake Louise Score, A total score of 3 to 5 indicates mild AMS. A score of 6 or more signifies severe AMS. Minimum value - 0, Maximum = 15
- Number of Participants With Side Effects [ Time Frame: 12 days ]
The typical side effects of acetazolamide will be measured daily (paresthesias of fingers and toes, change in urination frequency, and change in taste of beverages).
The side effect questionnaire included the following questions: In the past 12 h, have you experienced the following symptoms: Tingling of toes? Tingling of fingers? Increase in urination? Taste change of beverages? Symptoms were self-reported and rated on a 0-5 scale (0=none, 5=maximum)
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): NCT01993667
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||McIntosh Scott, MD||University of Utah|