Trial Outcomes & Findings for Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing (NCT NCT01993667)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

130 participants

Primary outcome timeframe

12 days

Results posted on

2019-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Acetazolamide Normal Dose Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Acetazolamide Low Dose Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide
Overall Study STARTED	64	66
Overall Study COMPLETED	43	47
Overall Study NOT COMPLETED	21	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Acetazolamide Normal Dose Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Acetazolamide Low Dose Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide
Overall Study Insufficient data to analyze	16	16
Overall Study Insufficient altitude reached	3	1
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetazolamide Normal Dose n=43 Participants Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Acetazolamide Low Dose n=47 Participants Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Total n=90 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 12.7 • n=5 Participants	41.6 years STANDARD_DEVIATION 13.5 • n=7 Participants	43.8 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days

Population: Seventy-three participants had sufficient data to be included in the analysis.

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

Outcome measures

Outcome measures
Measure	Acetazolamide Normal Dose n=35 Participants Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Acetazolamide Low Dose n=38 Participants Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide
Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score	21 Participants	21 Participants

SECONDARY outcome

Timeframe: 12 days

Population: These participants had sufficient data to be included in the analysis.

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)

Outcome measures

Outcome measures
Measure	Acetazolamide Normal Dose n=35 Participants Experimental : Acetazolamide 125 mg twice daily Acetazolamide: Administration of low dose acetazolamide	Acetazolamide Low Dose n=38 Participants Experimental: Acetazolamide 62.5 mg twice daily Acetazolamide: Administration of low dose acetazolamide
Number of Participants With Side Effects	6 Participants	7 Participants

Adverse Events

Acetazolamide Normal Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetazolamide Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott McIntosh, MD, MPH

University of Utah

Phone: 801-581-2730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place