Status:
COMPLETED
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Lead Sponsor:
University of California, San Francisco
Conditions:
High Altitude
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 pr...
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 le...
Eligibility Criteria
Inclusion
- healthy subjects The group of subjects in this experiment will be composed of healthy adult volunteers, over age 18 and under age 65, of any ethnic group, in good physical and mental health. We expect to enroll approximately 20 subjects. The ethnic groups represented will depend on the ethnicity of those who wish to be subjects, but no ethnic groups will be specifically sought after or rejected.
Exclusion
- Subjects will be specifically excluded according to the following criteria:
- History of any clinically significant medical condition, particularly abnormal respiratory, cardiovascular, neurological, hematological, renal or hepatic function. A medical history and physical exam will be performed at the screening session for each subject. We will use this to determine whether the subjects are healthy and without any history of these conditions. No laboratory workup will be required
- Regular smokers (more than 1 cigarette or cigar per day).
- Currently active or recently treated systemic or serious local infection.
- Recent regular use of prescription medications or regular physician care for any significant medical condition.
- A history of high altitude pulmonary edema or high altitude cerebral edema.
- Recent exposure to altitude (\>8000 ft) in the last month or having slept at an altitude \>6000 feet in the last month.
- Inability to provide written informed consent or to be able to complete the experiment.
- Pregnancy as determined by a urine pregnancy test if subjects believe they might be pregnant
- Allergy to non-steroid anti-inflammatory drugs (NSAIDs) or subjects reporting history or symptoms of ulcers or other ibuprofen related contraindications discussed with the screening physician.
- Heavy coffee drinkers or caffeine users will be advised that they may suffer rebound headache when restricted from caffeinated beverages on measurement days, and asked to carefully consider any continuing participation in the study after abstaining from caffeine during their first sea level measurements.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02233582
Start Date
September 1 2014
End Date
June 1 2017
Last Update
April 6 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
White Mountain Research Center
Bishop, California, United States, 95740
2
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94143