NCT03525561

Acetazolamide and Exercise Performance at Altitude

Completed EARLY_PHASE1 Last updated 5 July 2019

What this trial tests

EARLY_PHASE1 trial testing Acetazolamide Pill in Hypoxia in 10 participants. Completed in 15 May 2019.

Timeline

10 October 2018

Primary endpoint
15 May 2019

15 May 2019

Quick facts

Lead sponsor	United States Army Research Institute of Environmental Medicine
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	10
Start date	10 October 2018
Primary completion	15 May 2019
Estimated completion	15 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Acetazolamide Pill — full drug profile →
• Placebo pill — full drug profile →

Conditions studied

• Hypoxia — all drugs for Hypoxia →
• Exercise Performance — all drugs for Exercise Performance →
• Cognitive Function — all drugs for Cognitive Function →
• Dexterity — all drugs for Dexterity →

Sponsor

United States Army Research Institute of Environmental Medicine

Who can join

Adults 18 to 45, any sex, with Hypoxia or Exercise Performance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 ascend to a simulated altitude of 3500 m, where they will remain for 30 hr. Volunteers will rest at altitude for an hr, after which they will complete an AMS questionnaire, resting ventilation measurements, provide a blood sample and complete cognitive and finger dexterity testing. Subjects will then perform 15 minutes (min) of steady state (SS) treadmill exercise at 40-45% of SL VO2peak and a 2 mile treadmill time trial (TT). Volunteers will stay overnight in the hypobaric chamber with research staff supervision. The following morning, metabolic and blood measurements will again be completed, after which volunteers will perform the exercise testing for a second time. Cognitive and finger dexterity testing will be performed before volunteers return to sea level (i.e., "descend" from the simulated altitude). The results of the proposed study will, for the first time, provide quantitative evidence regarding whether AZ treatment impairs endurance exercise performance in the context of a Warfighter-relevant endurance exercise task.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.