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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mountain Sickness; Erythrocytosis

Treatments: Drug: N-acetylcysteine; Drug: Placebo pills; Drug: Acetazolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01187108

10-0078

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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85 participants in 4 patient groups, including a placebo group

Placebo pills

Placebo Comparator group

Treatment:

Drug: Placebo pills

Acetazolamide alone

Active Comparator group

Treatment:

Drug: Placebo pills

Drug: Acetazolamide

N-acetylcysteine alone

Active Comparator group

Treatment:

Drug: Placebo pills

Drug: N-acetylcysteine

Combination of N-acetylcysteine and acetazolamide

Active Comparator group

Treatment:

Drug: Acetazolamide

Drug: N-acetylcysteine