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

Sponsor

Oxford University Clinical Research Unit, Vietnam (Other)

Overall Status

Completed

CT.gov ID

NCT01418157

Collaborator

University of Oxford (Other), Wellcome Trust (Other), Mountain Medicine Society of Nepal (Other)

380

Enrollment

Location

Arms

Duration (Months)

189.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acetazolamide	Drug: Acetazolamide 125 mg twice daily until 4380 meters altitude
Placebo Comparator: Placebo	Drug: Placebo Twice daily

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

Primary Outcome Measures

Diagnosis of acute mountain sickness [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.
Diagnosis of acute mountain sickness [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

Blood oxygen saturation [Upon reaching an altitude of 3300m, average expected time is 1 day]
Percent
Heart rate [Upon reaching an altitude of 3300m, average expected time is 1 day]
Beats per minute
High altitude headache [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.
Blood oxygen saturation [Upon reaching an altitude of 4380m, average expected time is 3 days]
Percent
Heart rate [Upon reaching an altitude of 4380m, average expected time is 3 days]
Beats per minute
High altitude headache [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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