- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536429
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the postural control in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.
An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Bishkek, Kyrgyzstan, 720040
- National Center of Cardiology and Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy men and women, age 40-75 yrs, without any disease and need of medication.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
- Kyrgyz ethnicity
Exclusion Criteria:
- Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
- Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol.
- Allergy to acetazolamide and other sulfonamides.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ACETAZOLAMIDE oral capsule
Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally.
Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
|
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
|
PLACEBO_COMPARATOR: PLACEBO oral capsule
Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally.
Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
|
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anterio-posterior sway velocity (AP)
Time Frame: Day 2 at 760m and 3'100m
|
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of AP sway velocity between acetazolamide and placebo group, measured by a balance platform
|
Day 2 at 760m and 3'100m
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in arterial oxygen saturation
Time Frame: Day 2 at 760m and 3'100m
|
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oximetry
|
Day 2 at 760m and 3'100m
|
Acute mountain sickness, severity
Time Frame: Day 2 at 3'100m
|
Difference in acute mountain sickness severity on day 2 at 3'100 meters a.s.l. between acetazolamide and placebo group.
|
Day 2 at 3'100m
|
Change in cerebral tissue oxygenation
Time Frame: Day 2 at 760m and 3'100m
|
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of cerebral tissue oxygenation between acetazolamide and placebo group, measured by near-infrared spectroscopy.
|
Day 2 at 760m and 3'100m
|
Change in muscle tissue oxygenation
Time Frame: Day 2 at 760m and 3'100m
|
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of muscle tissue oxygenation between acetazolamide and placebo group, measured by near-infrared spectroscopy.
|
Day 2 at 760m and 3'100m
|
AP sway velocity with and without study medication
Time Frame: Day 3 at 760m
|
Difference in AP sway velocity between acetazolamide and placebo group at 760 m.
|
Day 3 at 760m
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-01-8/305A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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