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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| Wellcome Trust | OTHER |
| Mountain Medicine Society of Nepal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | 125 mg twice daily until 4380 meters altitude |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen saturation | Percent | Upon reaching an altitude of 3300m, average expected time is 1 day |
| Heart rate | Beats per minute | Upon reaching an altitude of 3300m, average expected time is 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Buddha Basnyat, MD PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Clinical Research Unit Nepal | Kathmandu | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23098412 | Result | 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. |
| Label | URL |
|---|---|
| Mountain Medicine Society Nepal | View source |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Twice daily |
|
| 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 |
| Blood oxygen saturation | Percent | Upon reaching an altitude of 4380m, average expected time is 3 days |
| Heart rate | Beats per minute | Upon reaching an altitude of 4380m, average expected time is 3 days |
| 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 |
| Oxford University Clinical Research Unit Viet Nam | View source |
| Oxford University Clinical Research Unit Nepal | View source |
| Trial Informed Consent Form, approvals and additional information | View source |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |