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 — DRUG
    Acetazolamide 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 — DEVICE
    Not 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 treatment
    Acetazolamide 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 Treatment
    This 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)

FacilityCityStateZIPSite coordinators
University of California, RiversideRiversideCalifornia92521-

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