Acetazolamide + Erythropoietin for Altitude Sickness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether erythropoietin and acetazolamide (a medication often used to prevent altitude sickness) can reduce altitude sickness and enhance physical performance at high altitudes. The research involves spending time at various altitudes, including a two-week stay on Pikes Peak, to evaluate the effectiveness of these treatments. It seeks healthy individuals who run regularly and can complete a two-mile run in 21 minutes or less. Participants must be willing to stay at high altitudes and adhere to specific exercise and diet restrictions during the trial. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking any prescription or over-the-counter medications, except contraceptives, unless approved by the study's medical team.
What is the safety track record for these treatments?
Research has shown that acetazolamide is generally safe and effective for altitude sickness. It helps individuals acclimate to high altitudes and reduces symptoms such as headaches and dizziness. Most people do not experience serious side effects, though some may have mild issues like blurred vision.
The FDA has approved erythropoietin for treating anemia, indicating a known safety record. However, like any treatment, it can cause side effects. This study uses both acetazolamide and erythropoietin together to determine if they can prevent altitude sickness. As the trial is in a later phase, there is strong evidence of safety, but participants should be aware of the potential for mild side effects from both medications.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about combining acetazolamide and erythropoietin for altitude sickness because this approach could enhance the body's ability to adapt to high altitudes more effectively than current treatments. While acetazolamide is already used to prevent and reduce the symptoms of altitude sickness by helping balance the body's acid-base levels, adding erythropoietin introduces a new dimension by potentially boosting red blood cell production, which can improve oxygen delivery throughout the body. This dual approach targets both the respiratory and hematological challenges of high altitudes, potentially offering quicker and more comprehensive relief than the standard treatment of acetazolamide alone.
What evidence suggests that this trial's treatments could be effective for altitude sickness?
Research has shown that acetazolamide, one of the treatments in this trial, effectively prevents altitude sickness, also known as acute mountain sickness (AMS). It significantly reduces the risk of severe AMS compared to a placebo, with studies finding a relative risk of 0.70. Acetazolamide increases oxygen levels in the blood, easing symptoms like headache, nausea, and weakness. Another arm of this trial will investigate the combination of erythropoietin with acetazolamide, although acetazolamide alone already has a strong track record for preventing altitude sickness.16789
Who Is on the Research Team?
Roy Salgado, PhD
Principal Investigator
United States Army Research Institute of Environmental Medicine
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-40 who are up to date with COVID-19 vaccinations, run regularly, and can complete a two-mile run within a specific time. Participants must avoid exercise, alcohol, and caffeine before testing sessions and be willing to live at high altitude for 15 days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sea Level Baseline Testing
Orientation, VO2peak assessments, treadmill time-trials, resting ventilation, venipuncture, capillary blood collection, and Hbmass assessment
Moderate Altitude Exposure
VO2peak and treadmill time-trial at 3,000 m
Intervention
Participants receive erythropoietin or placebo for 4 weeks
High Altitude Acclimatization
Participants reside at 4,300 m for 15 days with multiple assessments
Deacclimatization
Assessment of changes in hematological biomarkers after returning from high altitude
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acetazolamide
- Erythropoietin
Trial Overview
The study tests if erythropoietin (Procrit) and acetazolamide help maintain physical performance and reduce sickness when exposed to moderate (3,000 m) and high altitudes (4,300 m). It's randomized and double-blind with five phases including baseline testing, medication/placebo intake, exposure to different altitudes, acclimatization period at Pikes Peak summit for 15 days followed by deacclimatization.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Erythropoietin (subcutaneously) 50 IU /kg three times a week for 4 weeks. After the 4 week Erythropoietin, acetazolamide (orally) 250 mg twice a day for 3 1/2 days.
Acetazolamide (orally) 250 mg twice a day for 3 1/2 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
United States Army Research Institute of Environmental Medicine
Lead Sponsor
University of Puget Sound
Collaborator
Published Research Related to This Trial
Citations
Efficacy of acetazolamide for the prophylaxis of acute ...
Acetazolamide treatment showed to have significantly lower incidence of severe AMS compared with placebo (RR = 0.70, 95% CI, 0.52–0.95; P = 0.02; I2 = 3.6%).
The efficacy and safety of acetazolamide in chronic mountain ...
Numerous studies have shown that ACZ is effective in preventing AMS in healthy lowlanders traveling to high-altitude regions [20,21], and it also prevents ...
Sickness Evaluation at Altitude With Acetazolamide ...
A randomized controlled trial confirmed effectiveness of acetazolamide 125mg twice daily in prevention of AMS when started prior to ascent. In this study, it ...
A Randomized Controlled Trial of the Lowest Effective ...
Acetazolamide 62.5 mg twice daily failed to demonstrate equal effectiveness to 125 mg twice daily for prevention of acute mountain sickness.
Altitude, Acute Mountain Sickness, and Acetazolamide
Doses 500–750 mg/day within 24 hours of altitude exposure appear to be the most effective for minimizing symptoms of AMS.
6.
cdc.gov
cdc.gov/yellow-book/hcp/environmental-hazards-risks/high-altitude-travel-and-altitude-illness.htmlHigh-Altitude Travel and Altitude Illness | Yellow Book
Consider using acetazolamide to speed acclimatization if abrupt ascent is unavoidable. Avoid alcohol for the first 48 hours at high altitude. If ...
[Prevention of altitude sickness]
Persons taking Acetazolamide were more efficient and better prepared to cope with the extreme situations in high altitude. They also showed to be more resistent ...
Acute Mountain Sickness - StatPearls - NCBI Bookshelf - NIH
Acetazolamide is the most commonly used pharmacologic agent for both prophylaxis and treatment of AMS. As a carbonic anhydrase inhibitor, ...
Acetazolamide (oral route) - Side effects & dosage
Adults—500 to 1000 milligrams (mg) in divided doses, taken 24 to 48 hours before climbing, then continue for 48 hours while on high altitude or ...
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