Brief Title
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude
Official Title
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Brief Summary
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.
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Change in anterio-posterior sway velocity (AP)
Secondary Outcome
Change in arterial oxygen saturation
Condition
Altitude Hypoxia
Intervention
ACETAZOLAMIDE oral capsule
Study Arms / Comparison Groups
ACETAZOLAMIDE oral capsule
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
99
Start Date
May 15, 2018
Completion Date
August 2, 2018
Primary Completion Date
August 2, 2018
Eligibility Criteria
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.
Gender
All
Ages
40 Years - 75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Konrad E Bloch, MD, ,
Location Countries
Kyrgyzstan
Location Countries
Kyrgyzstan
Administrative Informations
NCT ID
NCT03536429
Organization ID
2018-01-8/305A
Responsible Party
Sponsor
Study Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Study Sponsor
Konrad E Bloch, MD, Study Chair, University Hospital, Zürich
Verification Date
October 2021