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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#14-14110 | Other Identifier | UCSF IRB |
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Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute mountain sickness such as headache and malaise. However, the blunting of inflammation by ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of inflammation for adjustments in breathing.
The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at altitude than will placebo subjects.
The study will begin with 2 days of studies in San Francisco (sea level baseline). Measurements will include non-invasive measurements of blood and tissue oxygen and venous blood draws for cytokine levels.
The altitude part of the study involves ascent to the University of California's White Mountain Research Center Barcroft Laboratory, at 12,500 feet elevation. The subjects will remain at that altitude for at least 48 hours for measurements of oxygenation and blood cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen plus ascent to high altitude | Experimental | subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude. |
|
| sugar pill plus ascent to high altitude | Placebo Comparator | subjects randomized to this arm will receive the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood cytokine levels | venous blood sample, once a day | on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days |
| cerebral blood flow | optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device | once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| pulse oximetry | finger pulse oximetry with an FDA approved pulse oximeter | once a day for 2 days at sea level, on arrival at altitude and daily for 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| cerebral oximetry | non-invasive measurements of cerebral oxygenation with an FDA approved device | once daily for 2 days at sea level, on arrival at altitude and daily for 2 days |
| acute mountain sickness inventory |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be specifically excluded according to the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Bickler, PhD/MD | University of California, San Francisco | Principal Investigator |
| John Feiner, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White Mountain Research Center | Bishop | California | 95740 | United States | ||
| UCSF Hypoxia Research Laboratory |
Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.
To study completion.
De-identified data set only.
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Sugar pill | Drug |
|
standard questionnaire concerning symptoms associated with acute mountain sickness
| once a day at both sea level (2 days) and altitude (2 days) |
| San Francisco |
| California |
| 94143 |
| United States |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |