Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

NCT ID: NCT05575180

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2024-02-22

Brief Summary

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.

Conditions

High Altitude Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Methazolamide

Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Group Type: EXPERIMENTAL

Methazolamide Pill

Intervention Type: DRUG

Oral Methazolamide

Acetazolamide

Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Group Type: ACTIVE_COMPARATOR

Acetazolamide 250Mg Tab

Intervention Type: DRUG

Oral acetazolamide

Placebo

Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo

Interventions

Acetazolamide 250Mg Tab

Oral acetazolamide

Intervention Type: DRUG

Methazolamide Pill

Oral Methazolamide

Intervention Type: DRUG

Placebo

Oral placebo

Intervention Type: DRUG

Eligibility Criteria

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:

1. Cardiovascular - e.g., hypertension

2. Metabolic - e.g., type 1 or 2 diabetes

3. Respiratory - e.g., chronic obstructive pulmonary disease, asthma

4. Digestive - e.g., ulcerative colitis

5. Arthritis

6. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wilderness Medical Society

UNKNOWN

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

43720

Identifier Type: -

Identifier Source: org_study_id