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Completed

NCT Number: NCT05575180

Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.

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Key information

Conditions

High Altitude Effects Altitude Sickness Behavior Motor Activity Respiration Disorders Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent provided
  • Between ages of 18-40 years old
  • In good general health as evidences by medical history
  • Perform at least 150 mins of aerobic exercise per week, and engage in physical activity >2 days a week
  • Completed in an endurance event in the last 12 months
  • Ability to take oral medication, and be willing to adhere to the drug regimen
  • Be willing to have blood samples taken

Exclusion criteria

  • Weigh 49kg or less, or are Obese (BMI >30 kg/m2)
  • Presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders:
  • Cardiovascular - e.g., hypertension
  • Metabolic - e.g., type 1 or 2 diabetes
  • Respiratory - e.g., chronic obstructive pulmonary disease, asthma
  • Digestive - e.g., ulcerative colitis
  • Arthritis
  • Cancer
  • Presence of any disorder or condition listed in the health screening questionnaire (see section 12.1)
  • Current use of Lonafarnib, Methenamine, Topamax, or steroids/corticosteroids
  • Known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or sulfonamides
  • Presence of bleeding or clotting disorders
  • Current smoker or cannabis user
  • Pregnant, suspect to be pregnant, currently planning a pregnancy, or nursing
  • Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Treatment and study plan

Acetazolamide 250Mg Tab

Drug

Oral acetazolamide

Methazolamide Pill

Drug

Oral Methazolamide

Placebo

Drug

Oral placebo

Primary outcomes

  1. Time to complete a 5 km time trial after each experimental day (Days 3-5)

    Time frame: The time to complete the 5 km time trial is measured after each time trial. The investigators will be blinded until all participants have completed each trial

    Primary endpoint is the time to complete a 5 km exercise task in the three arms of the trial (acetazolamide, methazolamide, placebo)

Secondary outcomes

  1. Expired Minute Ventilation

    Time frame: The average minute ventilation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial

    The secondary endpoint expired minute ventilation will be measured using a flow meter (pneumotach) which measure flow and allows for the calculation of ventilation. The value is expressed in liters per min and measured continuously

  2. Oxyhemoglobin saturation

    Time frame: The average oxyhemoglobin saturation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial

    The secondary endpoint oxyhemoglobin saturation will be measured using a pulse oximeter which measure the fraction of hemoglobin bound to oxygen. The value is expressed as a percent and measured continuously

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Wilderness Medical Society

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2022
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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