Phase 4
N=130
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Prophylaxis of Acute Mountain Sickness
Bottom Line
View on ClinicalTrials.gov: NCT01993667 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score — 21; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Low Dose Acetazolamide (Drug); Normal Dose Acetazolamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score |
21; 21 | — |
| SECONDARY Number of Participants With Side Effects |
6; 7 | — |
Summary
This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.
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
Data sourced from ClinicalTrials.gov (NCT01993667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.