Sickness Evaluation at Altitude With Acetazolamide at Relative Doses

Summary

The specific aim of this study is to evaluate whether acetazolamide 125mg daily is no worse than acetazolamide 250mg daily in decreasing the incidence of acute mountain sickness (AMS) in travelers to high altitude. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California

Timeline

Start

2019-08-09

Primary completion

2019-09-29

Completion

2019-09-29

Outcome

Missed primary endpoint

paper The 62.5-mg group failed to fall within the prespecified 26% noninferiority margin for acute mountain sickness incidence PMID 32479750 ↗

Publications

• Background van Patot MC, Leadbetter G 3rd, Keyes LE, Maakestad KM, Olson S, Hackett PH. Prophylactic low-dose acetazolamide reduces the incidence and severity of acute mountain sickness. High Alt Med Biol. 2008 Winter;9(4):289-93. doi: 10.1089/ham.2008.1029.
• Background Leaf DE, Goldfarb DS. Mechanisms of action of acetazolamide in the prophylaxis and treatment of acute mountain sickness. J Appl Physiol (1985). 2007 Apr;102(4):1313-22. doi: 10.1152/japplphysiol.01572.2005. Epub 2006 Oct 5.
• Background Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available.
• Lipman GS, Jurkiewicz C, Burnier A, Marvel J, Phillips C, Lowry C, Hawkins J, Navlyt A, Swenson ER. A Randomized Controlled Trial of the Lowest Effective Dose of Acetazolamide for Acute Mountain Sickness Prevention. Am J Med. 2020 Dec;133(12):e706-e715. doi: 10.1016/j.amjmed.2020.05.003. Epub 2020 May 29.

Drugs

Indications