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This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide normal dose | Active Comparator | Experimental : Acetazolamide 125 mg twice daily |
|
| Acetazolamide low dose | Experimental | Experimental: Acetazolamide 62.5 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Acetazolamide | Drug | Administration of low dose acetazolamide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| McIntosh Scott, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetazolamide Normal Dose | Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide |
| FG001 | Acetazolamide Low Dose | Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetazolamide Normal Dose | Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide |
| BG001 | Acetazolamide Low Dose | Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Seventy-three participants had sufficient data to be included in the analysis. | Posted | Count of Participants | Participants | 12 days |
|
12 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetazolamide Normal Dose | Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott McIntosh, MD, MPH | University of Utah | 801-581-2730 | Scott.McIntosh@hsc.utah.edu |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Normal Dose Acetazolamide | Drug | Administration of normal dose acetazolamide |
|
|
| 12 days |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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) | These participants had sufficient data to be included in the analysis. | Posted | Count of Participants | Participants | 12 days |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Acetazolamide Low Dose | Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide | 0 | 47 | 0 | 47 | 0 | 47 |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |