Ibuprofen
DrugWe are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Other names: motrin
NCT Number: NCT02233582
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
White Mountain Research Center, Bishop, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be specifically excluded according to the following criteria:
We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Other names: motrin
Time frame: on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days
venous blood sample, once a day
Time frame: once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days
optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device
Time frame: once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
finger pulse oximetry with an FDA approved pulse oximeter
Time frame: once daily for 2 days at sea level, on arrival at altitude and daily for 2 days
non-invasive measurements of cerebral oxygenation with an FDA approved device
Time frame: once a day at both sea level (2 days) and altitude (2 days)
standard questionnaire concerning symptoms associated with acute mountain sickness
University of California, San Francisco
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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