Acetazolamide and Exercise Performance at Altitude
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|ClinicalTrials.gov Identifier: NCT03525561|
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypoxia Exercise Performance Cognitive Function Dexterity||Drug: Acetazolamide Pill Drug: Placebo pill||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Subjects will serve as their own controls. Will exercise during simulated altitude exposure twice, once with acetazolamide and once with placebo.|
|Masking Description:||Single-blind use of acetazolamide where participant is not informed. Goal is to evaluate effect (or lack thereof) on exercise performance.|
|Primary Purpose:||Basic Science|
|Official Title:||Influences of Acetazolamide on Endurance Exercise Performance and Cognitive Function During Acute Exposure to Hypobaric Hypoxia|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Active Comparator: acetazolamide arm
This is the arm of the study in which the volunteers will take the acetazolamide (Diamox) pill.
Drug: Acetazolamide Pill
Subjects will take acetazolamide pill (Diamox), 500 mg/ day, and assess effect on exercise performance during 30-hour exposure to 3,500 m simulated altitude.
Other Name: Diamox
Placebo Comparator: placebo arm
This is the arm of the study in which volunteers will take the placebo.
Drug: Placebo pill
Subjects will take placebo pill and then we will assess exercise performance during 30-hour exposure to 3,500 m simulated altitude.
- Endurance exercise performance [ Time Frame: Exercise performance will be assessed during a 30-hour simulated altitude exposure, once during placebo and once during acetazolamide administration ]the primary outcome measure is performance of a 2-mile treadmill time trial (self-paced) at simulated altitude.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525561
|Contact: Robert Roussel, Ph.D.||email@example.com|
|Contact: Karleigh Bradbury, M.S.||firstname.lastname@example.org|
|United States, Massachusetts|
|Natick Soldier Systems Center||Recruiting|
|Natick, Massachusetts, United States, 01760|
|Contact: Robert R Roussel, PhD|
|Principal Investigator: Nisha Charkoudian, PhD|
|Principal Investigator:||Nisha Charkoudian, Ph.D.||United States Army Research Institute of Environmental Medicine|