Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude

Altitude Hypoxia Clinical Trial

Official title:

Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536520
• Other study ID #: 2018-01-8/305D
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2018
• Est. completion date: August 2, 2018

Study information

• Verified date: October 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, placebo controlled trial evaluating the effect of acetazolamide on visuo-motor learning performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Description:

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on visuo-motor learning performance 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Hypoxia
• Altitude Sickness
• Hypoxia

Intervention

Drug:
• ACETAZOLAMIDE oral capsule
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
• Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group	Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group	Day 2 at 760m and 3'100m
Secondary	Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m	Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m in the placebo and in the acetazolamide group	Day 1 and 2 at 760 m and at 3'100m
Secondary	Change in arterial oxygen saturation	Difference in altitude-induced change of arterial oxygen saturation from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo group, measured by pulse oxymetry	Day 1 and 2 at 760 m and at 3'100m