Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude

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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