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Trial record 1 of 1 for:    NCT01418157
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A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

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ClinicalTrials.gov Identifier: NCT01418157
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : June 24, 2013
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Mountain Medicine Society of Nepal
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Study Description
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Brief Summary:

Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter.

This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations.

This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue.

The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.


Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: Acetazolamide Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acetazolamide Drug: Acetazolamide
125 mg twice daily until 4380 meters altitude
Placebo Comparator: Placebo Drug: Placebo
Twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.

  2. Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.


Secondary Outcome Measures :
  1. Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Percent

  2. Heart rate [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    Beats per minute

  3. High altitude headache [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ]
    High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.

  4. Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Percent

  5. Heart rate [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    Beats per minute

  6. High altitude headache [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ]
    High altitude headache severity will be scored in millimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nepalese national
  • Aged 18 to 65
  • Travelling directly from Dhunche to Gosainkunda
  • Rapid ascent as defined by ascent within 3 days

Exclusion Criteria:

  • Use of any drugs for the prevention of altitude sickness or headache
  • Current illness
  • Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
  • Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
  • One night within the last 30 days spent at an altitude of 4500 metres or above
  • Residents of altitude more than 2500m
  • A known drug allergy to sulfonamides.
  • Treatment with any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen.
  • Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri
  • Known severe uncontrolled headache syndrome
  • Diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418157


Locations
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Nepal
Oxford University Clinical Research Unit Nepal
Kathmandu, Nepal
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
University of Oxford
Wellcome Trust
Mountain Medicine Society of Nepal
Investigators
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Principal Investigator: Buddha Basnyat, MD PhD University of Oxford
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01418157    
Other Study ID Numbers: 04NP
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Acute mountain sickness
Rapid ascent
High altitude headache
Mountain Medicine Society Nepal
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs