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

Acute Mountain Sickness Clinical Trial

Official title:

Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418157
• Other study ID #: 04NP
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2011
• Last updated: June 21, 2013
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Drug:
• Acetazolamide
125 mg twice daily until 4380 meters altitude
• Placebo
Twice daily

Locations

Country	Name	City	State
Nepal	Oxford University Clinical Research Unit Nepal	Kathmandu

Sponsors (4)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Mountain Medicine Society of Nepal, University of Oxford, Wellcome Trust

Country where clinical trial is conducted

Nepal, 

References & 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 Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Blood oxygen saturation	Percent	Upon reaching an altitude of 3300m, average expected time is 1 day	No
Secondary	Heart rate	Beats per minute	Upon reaching an altitude of 3300m, average expected time is 1 day	No
Secondary	High altitude headache	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.	Upon reaching an altitude of 3300m, average expected time is 1 day	No
Secondary	Blood oxygen saturation	Percent	Upon reaching an altitude of 4380m, average expected time is 3 days	No
Secondary	Heart rate	Beats per minute	Upon reaching an altitude of 4380m, average expected time is 3 days	No
Secondary	High altitude headache	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.	Upon reaching an altitude of 4380m, average expected time is 3 days	No

External Links

•   Mountain Medicine Society Nepal
•   Oxford University Clinical Research Unit Nepal
•   Oxford University Clinical Research Unit Viet Nam
•   Trial Informed Consent Form, approvals and additional information