NCT02233582

Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• High Altitude

Interventions

Type	Name	Description
DRUG	Ibuprofen	We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
DRUG	Sugar pill

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-10-01
• Completion: 2017-06-01
• First posted: 2014-09-08
• Last updated: 2021-04-06

Locations

2 sites across 1 country: United States