A Phase 1 interventional study of Ibuprofen and Sugar pill in High Altitude, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Basic science
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.
189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.
This study's enrollment of 20 is below the median of 33 across 157 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be specifically excluded according to the following criteria:
subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.
Drug: Ibuprofen
subjects randomized to this arm will receive the placebo
Drug: Sugar pill
We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Also known as: motrin
blood cytokine levels
venous blood sample, once a day
Time frame: 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
Time frame: once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days
pulse oximetry
finger pulse oximetry with an FDA approved pulse oximeter
Time frame: once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
cerebral oximetry
non-invasive measurements of cerebral oxygenation with an FDA approved device
Time frame: once daily for 2 days at sea level, on arrival at altitude and daily for 2 days
acute mountain sickness inventory
standard questionnaire concerning symptoms associated with acute mountain sickness
Time frame: once a day at both sea level (2 days) and altitude (2 days)
Plan to share: Yes — Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco