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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prophylaxis of Acute Mountain Sickness
Interventions Drug: Low Dose Acetazolamide
Drug: Normal Dose Acetazolamide
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetazolamide Normal Dose Acetazolamide Low Dose
Hide Arm/Group Description

Experimental : Acetazolamide 125 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Experimental: Acetazolamide 62.5 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Period Title: Overall Study
Started 64 66
Completed 43 47
Not Completed 21 19
Reason Not Completed
Insufficient data to analyze             16             16
Insufficient altitude reached             3             1
Lost to Follow-up             2             2
Arm/Group Title Acetazolamide Normal Dose Acetazolamide Low Dose Total
Hide Arm/Group Description

Experimental : Acetazolamide 125 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Experimental: Acetazolamide 62.5 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Total of all reporting groups
Overall Number of Baseline Participants 43 47 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 47 participants 90 participants
46.2  (12.7) 41.6  (13.5) 43.8  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 47 participants 90 participants
Female
12
  27.9%
14
  29.8%
26
  28.9%
Male
31
  72.1%
33
  70.2%
64
  71.1%
1.Primary Outcome
Title Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score
Hide Description 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
Time Frame 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
Seventy-three participants had sufficient data to be included in the analysis.
Arm/Group Title Acetazolamide Normal Dose Acetazolamide Low Dose
Hide Arm/Group Description:

Experimental : Acetazolamide 125 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Experimental: Acetazolamide 62.5 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Overall Number of Participants Analyzed 35 38
Measure Type: Count of Participants
Unit of Measure: Participants
21
  60.0%
21
  55.3%
2.Secondary Outcome
Title Number of Participants With Side Effects
Hide Description

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)

Time Frame 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
These participants had sufficient data to be included in the analysis.
Arm/Group Title Acetazolamide Normal Dose Acetazolamide Low Dose
Hide Arm/Group Description:

Experimental : Acetazolamide 125 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Experimental: Acetazolamide 62.5 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Overall Number of Participants Analyzed 35 38
Measure Type: Count of Participants
Unit of Measure: Participants
6
  17.1%
7
  18.4%
Time Frame 12 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetazolamide Normal Dose Acetazolamide Low Dose
Hide Arm/Group Description

Experimental : Acetazolamide 125 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

Experimental: Acetazolamide 62.5 mg twice daily

Acetazolamide: Administration of low dose acetazolamide

All-Cause Mortality
Acetazolamide Normal Dose Acetazolamide Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/47 (0.00%) 
Hide Serious Adverse Events
Acetazolamide Normal Dose Acetazolamide Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/47 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetazolamide Normal Dose Acetazolamide Low Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/47 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Scott McIntosh, MD, MPH
Organization: University of Utah
Phone: 801-581-2730
EMail: Scott.McIntosh@hsc.utah.edu
Layout table for additonal information
Responsible Party: Scott McIntosh, University of Utah
ClinicalTrials.gov Identifier: NCT01993667    
Other Study ID Numbers: 50402
First Submitted: November 12, 2013
First Posted: November 25, 2013
Results First Submitted: November 26, 2018
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019