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NCT03525561 · ClinicalTrials.gov registry record · Early Phase 1
Acetazolamide and Exercise Performance at Altitude
A Early Phase 1 study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT03525561 is a Early Phase 1 study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 10 participants.
The verdict
NCT03525561, a Early Phase 1 study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goals of the present study are to evaluate whether the most common, and effective, treatment for acute mountain sickness (AMS), acetazolamide (AZ), has a negative, positive, or no influence on exercise performance, cognitive performance, or manual dexterity in young healthy subjects during simulated altitude exposure. AMS represents a serious challenge to the health and performance of the Warfighter who may need to rapidly deploy to high altitude. However, there have been concerns that AZ might alter or impair endurance exercise performance, and possibly fine motor skills. These would represent major limitations to the use of this drug in a Warfighter who has a specific timeframe in which to accomplish mission tasks. In the present project, we will use exposure to simulated altitude in the USARIEM hypobaric chamber to quantify the impact, if any, of AZ on endurance exercise performance following rapid ascent to 3500 meters (m) in unacclimatized lowlander volunteers. The study will be conducted using a randomized, single-blind, placebo-controlled crossover study design. Ten male and female volunteers will complete one orientation day, one VO2peak day, three days of familiarization testing at sea level (SL), then two rounds of experimental testing. Each round of experimental testing consists of six days including four days to establish baseline euhydration, followed by a 30 hour (hr) exposure to 3500 m. Volunteers will have a two week break between experimental testing rounds for washout of any effects of altitude acclimation. During one experimental round, volunteers will take two doses of AZ each day (Phase 1: 250 mg/dose,500 mg/day, Phase 2: 125 mg/dose, 250 mg/day) starting 48 hr prior to their altitude exposure and continuing for the 30 hr stay at high altitude. During the other experimental condition, volunteers will be given a placebo at the same time points as the doses of AZ. Prior to altitude exposure, AMS will be evaluated and volunteers will then ascen
Interventions
- DRUG Placebo pill
- DRUG Acetazolamide Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2019-05-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525561
The ClinicalTrials.gov registry entry for NCT03525561 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo pill is the first listed.
NCT03525561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03525561 about?
NCT03525561 is a clinical study titled "Acetazolamide and Exercise Performance at Altitude". The goals of the present study are to evaluate whether the most common, and effective, treatment for acute mountain sickness (AMS), acetazolamide (AZ), has a negative, positive, or no influence on exercise performance, cognitive performance, or manual dexterity in young healthy subjects during simul...
What is the current status of trial NCT03525561?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2018-10-10. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT03525561?
The interventions under investigation include: Placebo pill (DRUG), Acetazolamide Pill (DRUG).
Who is sponsoring clinical trial NCT03525561?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
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