Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing

Prophylaxis of Acute Mountain Sickness Clinical Trial

Official title:

Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993667
• Other study ID #: 50402
• Status: Completed
• Phase: Phase 4
• Start date: March 2012
• Est. completion date: November 2016

Study information

• Verified date: January 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• English or Indian speaking

• Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt. Everest

Exclusion Criteria:

• Low sodium and/potassium blood serum levels

• Kidney disease or dysfunction

• Liver disease, dysfunction, or cirrhosis

• Suprarenal gland failure or dysfunction

• Hyperchloremic acidosis

• Angle-closure glaucoma

• Taking high dose aspirin (over 325 mg/day)

• Any reaction to sulfa drugs or acetazolamide

• Pregnant or lactating women

Related Conditions & MeSH terms

• Altitude Sickness
• Prophylaxis of Acute Mountain Sickness

Intervention

Drug:
• Low Dose Acetazolamide
Administration of low dose acetazolamide
• Normal Dose Acetazolamide
Administration of normal dose acetazolamide

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score	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	12 days
Secondary	Number of Participants With Side Effects	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)	12 days