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Completed

NCT Number: NCT01993667

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dose Acetazolamide

Drug

Administration of low dose acetazolamide

Other names: Diamox

Normal Dose Acetazolamide

Drug

Administration of normal dose acetazolamide

Other names: Diamox

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.