Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Chronic mountain sickness is characterized by excessive red blood cell production which causes sludging of the vascular system. This high viscosity blood causes heart failure, cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been previously been shown to be an environmental pollutant worsens the overproduction of red blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt from the blood) are evaluated in their potential to improve chronic mountain sickness.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Jackson, Brian, M.S.; Thomas H Maren Foundation; Universidad Peruana Cayetano Heredia
• Treatments: Acetazolamide; Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Males over 17 years of age

• Hematocrit > 70%

• Chronic Mountain Sickness score (CMS) > 6

• Able to give informed consent and follow instructions in written Spanish

Exclusion Criteria:

• CMS > 15

• Underlying lung disease, smoking, or oxygen therapy

• Asthma (bronchospasm can be caused by N-acetylcysteine)

• Phlebotomy in last 3 months

• h/o adverse reaction to acetazolamide or N-acetylcysteine