A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent
1 other identifier
interventional
380
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 24, 2013
June 1, 2013
2 months
August 8, 2011
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnosis of acute mountain sickness
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.
Upon reaching an altitude of 3300m, average expected time is 1 day
Diagnosis of acute mountain sickness
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.
Upon reaching an altitude of 4380m, average expected time is 3 days
Secondary Outcomes (6)
Blood oxygen saturation
Upon reaching an altitude of 3300m, average expected time is 1 day
Heart rate
Upon reaching an altitude of 3300m, average expected time is 1 day
High altitude headache
Upon reaching an altitude of 3300m, average expected time is 1 day
Blood oxygen saturation
Upon reaching an altitude of 4380m, average expected time is 3 days
Heart rate
Upon reaching an altitude of 4380m, average expected time is 3 days
- +1 more secondary outcomes
Study Arms (2)
Acetazolamide
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Nepalese national
- Aged 18 to 65
- Travelling directly from Dhunche to Gosainkunda
- Rapid ascent as defined by ascent within 3 days
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxford University Clinical Research Unit, Vietnamlead
- University of Oxfordcollaborator
- Wellcome Trustcollaborator
- Mountain Medicine Society of Nepalcollaborator
Study Sites (1)
Oxford University Clinical Research Unit Nepal
Kathmandu, Nepal
Related Publications (1)
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.
PMID: 23098412RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Buddha Basnyat, MD PhD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 24, 2013
Record last verified: 2013-06