Clinical trial NCT01187108: Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru
Official title: Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Erythrocytosis
Mountain Sickness
Keywords: Cobalt
Excessive Erythrocytosis
Monge's Disease
Acetazolamide
N-acetylcysteine
Altitude Sickness
Chronic Mountain Sickness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
name: Jackson, Brian, M.S.
name: Thomas H Maren Foundation
First posted: 2010-08-23
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change from baseline in arterial blood gas values at week 8
timeFrame: Baseline and week 8
measure: Change from baseline Erythropoietin at week 8
timeFrame: Baseline and week 8
measure: Change from baseline in serum and urine Cobalt at day 3
timeFrame: Baseline and day 3
measure: Change in baseline urine protein at 8 weeks
timeFrame: Baseline and week 8
measure: Change in baseline Chronic mountain sickness score at 8 weeks
timeFrame: Baseline and week 8
measure: Changes in baseline Serum electrolytes at day 3, 14 and week 8
timeFrame: Baseline and Days 3, 14, and week 8
Other outcomes:
Locations:
city: Cerro de Pasco
country: Peru
facility: Chronic mountain sickness clinic
state: Pasco
Study officials:
affiliation: University of Colorado Denver Health Sciences Center
name: Richard Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Peruana Cayetano Heredia
name: Abdias Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver Health Sciences Center
name: Richard Fuquay, MD
role: STUDY_DIRECTOR
References:
citation: Jefferson JA, Escudero E, Hurtado ME, Pando J, Tapia R, Swenson ER, Prchal J, Schreiner GF, Schoene RB, Hurtado A, Johnson RJ. Excessive erythrocytosis, chronic mountain sickness, and serum cobalt levels. Lancet. 2002 Feb 2;359(9304):407-8. doi: 10.1016/s0140-6736(02)07594-3.
citation: Jefferson JA, Escudero E, Hurtado ME, Kelly JP, Swenson ER, Wener MH, Burnier M, Maillard M, Schreiner GF, Schoene RB, Hurtado A, Johnson RJ. Hyperuricemia, hypertension, and proteinuria associated with high-altitude polycythemia. Am J Kidney Dis. 2002 Jun;39(6):1135-42. doi: 10.1053/ajkd.2002.33380.
citation: Richalet JP, Rivera-Ch M, Maignan M, Privat C, Pham I, Macarlupu JL, Petitjean O, Leon-Velarde F. Acetazolamide for Monge's disease: efficiency and tolerance of 6-month treatment. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1370-6. doi: 10.1164/rccm.200802-196OC. Epub 2008 Apr 3.