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

Primary Purpose

Prophylaxis of Acute Mountain Sickness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low Dose Acetazolamide
Normal Dose Acetazolamide
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prophylaxis of Acute Mountain Sickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Utah Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acetazolamide normal dose

Acetazolamide low dose

Arm Description

Experimental : Acetazolamide 125 mg twice daily

Experimental: Acetazolamide 62.5 mg twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
November 12, 2013
Last Updated
January 10, 2019
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT01993667
Brief Title
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Official Title
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis of Acute Mountain Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide normal dose
Arm Type
Active Comparator
Arm Description
Experimental : Acetazolamide 125 mg twice daily
Arm Title
Acetazolamide low dose
Arm Type
Experimental
Arm Description
Experimental: Acetazolamide 62.5 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Low Dose Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Administration of low dose acetazolamide
Intervention Type
Drug
Intervention Name(s)
Normal Dose Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Administration of normal dose acetazolamide
Primary Outcome Measure Information:
Title
Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score
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
Secondary Outcome Measure Information:
Title
Number of Participants With Side Effects
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McIntosh Scott, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

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

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