Trial | NCT01187108  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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.
Study Started
Jun 30
2013
Primary Completion
Sep 30
2013
Study Completion
Sep 30
2013
Last Update
May 15
2015
Estimate

Drug N-acetylcysteine

NAC 600 mg oral once daily

  • Other names: Given in gel capsules

Drug Acetazolamide

Acetazolamide 250 mg oral once daily

  • Other names: Given in gel capsules

Drug Placebo pills

1 (or 2 in the placebo group) empty gel capsules

Placebo pills Placebo Comparator

Acetazolamide alone Active Comparator

N-acetylcysteine alone Active Comparator

Combination of N-acetylcysteine and acetazolamide Active Comparator

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
No Results Posted