A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
NCT ID: NCT01418157
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
380 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Acetazolamide
Acetazolamide
125 mg twice daily until 4380 meters altitude
Placebo
Placebo
Twice daily
Interventions
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Acetazolamide
125 mg twice daily until 4380 meters altitude
Placebo
Twice daily
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 65
* Travelling directly from Dhunche to Gosainkunda
* Rapid ascent as defined by ascent within 3 days
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Wellcome Trust
OTHER
Mountain Medicine Society of Nepal
OTHER
Oxford University Clinical Research Unit, Vietnam
OTHER
Responsible Party
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Principal Investigators
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Buddha Basnyat, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford University Clinical Research Unit Nepal
Kathmandu, , Nepal
Countries
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References
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Gertsch JH, Corbett B, Holck PS, Mulcahy A, Watts M, Stillwagon NT, Casto AM, Abramson CH, Vaughan CP, Macguire C, Farzan NN, Vo BN, Norvelle RJ, May K, Holly JE, Irons H, Stutz AM, Chapagain P, Yadav S, Pun M, Farrar J, Basnyat B. Altitude Sickness in Climbers and Efficacy of NSAIDs Trial (ASCENT): randomized, controlled trial of ibuprofen versus placebo for prevention of altitude illness. Wilderness Environ Med. 2012 Dec;23(4):307-15. doi: 10.1016/j.wem.2012.08.001. Epub 2012 Oct 24.
Related Links
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Mountain Medicine Society Nepal
Oxford University Clinical Research Unit Viet Nam
Oxford University Clinical Research Unit Nepal
Trial Informed Consent Form, approvals and additional information
Other Identifiers
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04NP
Identifier Type: -
Identifier Source: org_study_id
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