NCT01187108

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

Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erythrocytosis
• Mountain Sickness

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	NAC 600 mg oral once daily
DRUG	Acetazolamide	Acetazolamide 250 mg oral once daily
DRUG	Placebo pills	1 (or 2 in the placebo group) empty gel capsules

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-08-23
• Last updated: 2015-05-15

Locations

1 site across 1 country: Peru