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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993667
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Scott McIntosh, University of Utah

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE November 26, 2018
Results First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Prevention of acute mountain sickness as measured by the Lake Louise Score [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01993667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Side effect profile of acetazolamide [ Time Frame: 1 year ]
The typical side effects of acetazolamide will be measured via a 1-5 scale: Paresthesias of fingers and toes, change in urination frequency, and change in taste of beverages.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Official Title  ICMJE Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Brief Summary This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prophylaxis of Acute Mountain Sickness
Intervention  ICMJE
  • Drug: Low Dose Acetazolamide
    Administration of low dose acetazolamide
    Other Name: Diamox
  • Drug: Normal Dose Acetazolamide
    Administration of normal dose acetazolamide
    Other Name: Diamox
Study Arms  ICMJE
  • Active Comparator: Acetazolamide normal dose
    Experimental : Acetazolamide 125 mg twice daily
    Intervention: Drug: Normal Dose Acetazolamide
  • Experimental: Acetazolamide low dose
    Experimental: Acetazolamide 62.5 mg twice daily
    Intervention: Drug: Low Dose Acetazolamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2016)
130
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
100
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993667
Other Study ID Numbers  ICMJE 50402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott McIntosh, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: McIntosh Scott, MD University of Utah
PRS Account University of Utah
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP