A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
This study is currently recruiting participants.
Verified August 2011 by Oxford University Clinical Research Unit, Vietnam
Sponsor:
Oxford University Clinical Research Unit, Vietnam
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: August 19, 2011
Last verified: August 2011
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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 milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
| Estimated Enrollment: | 380 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418157
Contacts
| Contact: Buddha Basnyat, MD | 9851034187 | rishibas@wlink.com.np |
Locations
| Nepal | |
| Oxford University Clinical Research Unit Nepal | Recruiting |
| Kathmandu, Nepal | |
| Contact: Buddha Basnyat, MD 9851034187 rishibas@wlink.com.np | |
| Principal Investigator: Buddha Basnyat, MD | |
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
University of Oxford
Wellcome Trust
Mountain Medicine Society of Nepal
More Information
Additional Information:
No publications provided
| 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: | August 19, 2011 |
| 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 Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013