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A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Mountain Medicine Society of Nepal
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01418157
First received: August 8, 2011
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Acute Mountain Sickness
Drug: Acetazolamide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ] [ Designated as safety issue: No ]
    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.

  • Diagnosis of acute mountain sickness [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ] [ Designated as safety issue: No ]
    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:
  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ] [ Designated as safety issue: No ]
    Percent

  • Heart rate [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ] [ Designated as safety issue: No ]
    Beats per minute

  • High altitude headache [ Time Frame: Upon reaching an altitude of 3300m, average expected time is 1 day ] [ Designated as safety issue: No ]
    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.

  • Blood oxygen saturation [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ] [ Designated as safety issue: No ]
    Percent

  • Heart rate [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ] [ Designated as safety issue: No ]
    Beats per minute

  • High altitude headache [ Time Frame: Upon reaching an altitude of 4380m, average expected time is 3 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 380
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetazolamide Drug: Acetazolamide
125 mg twice daily until 4380 meters altitude
Placebo Comparator: Placebo Drug: Placebo
Twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418157

Locations
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
Principal Investigator: Buddha Basnyat, MD PhD Oxford University Clinical Research Unit, Nepal
  More Information

Additional Information:
Publications:
Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01418157     History of Changes
Other Study ID Numbers: 04NP
Study First Received: August 8, 2011
Last Updated: June 21, 2013
Health Authority: Nepal: Health Research Council

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:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Central Nervous System Agents
Diuretics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014