National Center of Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03536429
Randomized, placebo controlled trial evaluating the effect of acetazolamide on postural control in lowlanders older than 40 years travelling from 760 m to 3'100 m.
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Notify Me40 year–75 year
All sexes
Interventional
Phase 4
Bishkek, 720040, Kyrgyzstan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
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
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
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.
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.
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.
Time frame: Day 3 at 760m
Difference in AP sway velocity between acetazolamide and placebo group at 760 m.
University of Zurich
Other
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
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