Acetazolamide and Exercise Performance at Altitude

July 2, 2019 updated by: United States Army Research Institute of Environmental Medicine

Influences of Acetazolamide on Endurance Exercise Performance and Cognitive Function During Acute Exposure to Hypobaric Hypoxia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • Natick Soldier Systems Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Volunteers must meet all of the following criteria to be included in the study:

  • Male or female, age 18-45
  • In good health as determined by Office of Medical Support and Oversight (OMSO) General Medical Clearance
  • Passed his/her most recent Army Physical Fitness Test (APFT; military volunteers only) or exercise at least 2 times per week (civilian volunteers)
  • Willing to not exercise, drink alcoholic beverages, or consume caffeinated products for 24 hours before each testing session.
  • Willing not to consume carbonated beverages during the experimental phases of the study (this does not include the two week break between experimental phases)
  • Willing to stay and sleep in an altitude chamber (the size of a dorm room) ~60 hours total (two ~30 hr exposures).
  • Body mass index (BMI) ≤ 28.5

Exclusion Criteria:

  • Females who are pregnant or planning to become pregnant during the study
  • Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by OMSO and PI)
  • Born at altitudes greater than 2,100 m (~7,000 feet; Examples include Santa Fe, New Mexico; Laramie, Wyoming; Etc.)
  • Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas more than 1,200 m for five days or more within the last 2 months (Examples include Ft. Huachuca, Arizona; Lima, Peru; Feldberg, Germany; etc.)
  • Physical problems/injuries associated with walking or running on a treadmill
  • Allergy to skin adhesive
  • Abnormal blood count (For example: hemoglobin (Hb) outside of the normal ranges (Normal [Hb] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)
  • Prior HAPE (high altitude pulmonary edema) or HACE (high altitude cerebral edema) diagnosis
  • Smokers or tobacco/nicotine users (unless have quit more than 4 months prior)
  • Presence of asthma or respiratory tract infections (unless more than 1 month prior or approved by OMSO).
  • Allergy to sulfa drugs (Acetazolamide)
  • Evidence of apnea or other sleeping disorders
  • History of neurologic (e.g. stroke, seizure), speech, facial muscle disorder or injuries preventing from producing normal range of hand and finger motion
  • Experiencing colds, coughs, or sinus infections
  • Food allergies/intolerances to gluten and/or dairy
  • Low blood Na+/K+ values ( Na+: < 135 mmol/L, K+: <3.5 mmol/L)
  • Kidney, liver or adrenal dysfunction
  • Breastfeeding mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Exercise performance will be assessed during a 30-hour simulated altitude exposure, once during placebo and once during acetazolamide administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United States Army Research Institute of Environmental Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nisha Charkoudian, Ph.D., United States Army Research Institute of Environmental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-10729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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