The Role of Acetazolamide in Mitigating Inflammation and Innate Immune Activation at High Altitude
Part of paid clinical trials in Riverside, California.
- Sponsor
- University of California, Riverside
- Study ID
- NCT07517068
- Phase
- EARLY_PHASE1
- Status
- Active Not Recruiting
Conditions
- Acute Mountain Sickness (AMS)
- Hypoxemia
- Immune Response
- Inflammation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- ACETAZOLAMIDE oral capsule — DRUGAcetazolamide is administered orally in pill form at a 125 mg dose taken twice per day (morning and evening) starting 2 days before ascent to high altitude and each day while at high altitude.
- Placebo Arm — DEVICENot utilization of Acetazolamide (ACZ) oxygenation (SpO2) or any other supportive measurement will be used with this group.
Study Details
High altitude travel can lead to inflammation in the body and activation of innate immune cells. The investigators' prior research demonstrates that 1 to 3 days at 3800 m elevation leads to increased expression of genes in blood cells that code for proteins that signal cell damage (damage associated molecular patterns (DAMPs)), cell receptors involved in innate immune responses, as well as increases in monocyte and neutrophil cells which promote inflammation. This study will investigate the potential mechanisms underlying these effects using the drug Acetazolamide, a carbonic anhydrase inhibitor which is known to reduce symptoms of Acute Mountain Sickness.
Key Dates
- Start date
- Sep 17, 2025
- Status verified
- Apr 2026
- Primary completion
- Jun 15, 2026
- Completion
- Dec 15, 2026
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: Acetazolamide treatmentAcetazolamide is administered orally in pill form at a 125 mg dose taken twice per day (morning and evening) starting 2 days before ascent to high altitude and each day while at high altitude.
- Placebo Comparator: Placebo TreatmentThis group will not be provided ACZ. Instead, participants will take a placebo compound in pill form resembling ACZ on the same schedule as the ACZ treatment.
Primary Outcome Measure
Distributions of circulating immune cell subsets. [ Time Frame: From enrollment to 30 days following return from high altitude (approximately 1.5 months total). ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Riverside | Riverside | California | 92521 | - |
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