Sickness Evaluation at Altitude With Acetazolamide at Relative Doses

NCT03828474 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 49724
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Mountain Sickness

Keywords

acetazolamide; chemoprophylaxis; altitude

Outcome Measures

Primary Outcomes (1)

• Incidence of acute mountain sickness

  Incidence of acute mountain sickness by Lake Louise Questionnaire

  2 days

Study Arms (2)

Acetazolamide 125mg twice daily

EXPERIMENTAL

Acetazolamide pill 125mg twice daily by mouth, started the night prior to ascent and continued for 3 total doses

Drug: Acetazolamide Pill

Acetazolamide 62.5mg twice daily

EXPERIMENTAL

Acetazolamide pill 62.5mg twice daily by mouth, started the night prior to ascent and continued for 3 total doses

Drug: Acetazolamide Pill

Interventions

Acetazolamide Pill DRUG

Acetazolamide pill

Also known as: Diamox

Acetazolamide 125mg twice daily; Acetazolamide 62.5mg twice daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to complete moderate hike at altitude
• Live at elevation \< 4,000 ft
• Able to arrange own transportation to study site
• Available for full study duration (Friday night - Sunday morning)

You may not qualify if:

• Pregnancy
• Slept at altitude \> 4,000 ft within 1 week of study
• Allergy to acetazolamide or sulfa drugs
• NSAIDs, acetazolamide, or corticosteroids within 48 hours prior to study start
• History of severe anemia, severe heart disease, advanced COPD/emphysema or sickle cell disease

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

White Mountain Research Center

Bishop, California, 93514, United States

Location

Related Publications (4)

• 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.

  PMID: 19115912 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.

  PMID: 17023566 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.

  PMID: 11450659 BACKGROUND

• 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.

  PMID: 32479750 DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carrie Jurkiewicz, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Visually identical pills
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor, Department of Emergency Medicine

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: August 9, 2019
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)