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

Primary Purpose

Erythrocytosis, Mountain Sickness

Status
Completed
Phase
Phase 1
Locations
Peru
Study Type
Interventional
Intervention
N-acetylcysteine
Acetazolamide
Placebo pills
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythrocytosis focused on measuring Cobalt, Excessive Erythrocytosis, Monge's Disease, Acetazolamide, N-acetylcysteine, Altitude Sickness, Chronic Mountain Sickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Chronic mountain sickness clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo pills

Acetazolamide alone

N-acetylcysteine alone

Combination of N-acetylcysteine and acetazolamide

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8
Spun hematocrit measured on portable machine

Secondary Outcome Measures

Change from baseline in arterial blood gas values at week 8
Analyzed using portable machine. The values analyzed include serum pH, partial pressure of carbon dioxide, partial pressure of oxygen, and serum bicarbonate.
Change from baseline Erythropoietin at week 8
Serum hormone that stimulates red blood cell production
Change from baseline in serum and urine Cobalt at day 3
Will calculate spot clearance of cobalt
Change in baseline urine protein at 8 weeks
Ratio of urine total protein to urine creatinine
Change in baseline Chronic mountain sickness score at 8 weeks
Chronic Mountain Sickness Score Absent Mild Moderate Severe Headache 0 +1 +2 +3 Dizziness 0 +1 +2 +3 Failing Memory 0 +1 +2 +3 Fatigue 0 +1 +2 +3 Breathlessness 0 +1 +2 +3 Sleep disturbances 0 +1 +2 +3 Tinnitus 0 +1 +2 +3 Anorexia 0 +1 +2 +3 Cyanosis of lips, face, or fingers 0 +1 +2 +3 Hyperemia or prominent capillaries conjunctivae or laryngopharynx 0 +1 +2 +3
Changes in baseline Serum electrolytes at day 3, 14 and week 8
Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium < 3.0 meQ/L).

Full Information

First Posted
August 18, 2010
Last Updated
May 13, 2015
Sponsor
University of Colorado, Denver
Collaborators
Universidad Peruana Cayetano Heredia, Jackson, Brian, M.S., Thomas H Maren Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01187108
Brief Title
Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru
Acronym
CoCMS
Official Title
Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Universidad Peruana Cayetano Heredia, Jackson, Brian, M.S., Thomas H Maren Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythrocytosis, Mountain Sickness
Keywords
Cobalt, Excessive Erythrocytosis, Monge's Disease, Acetazolamide, N-acetylcysteine, Altitude Sickness, Chronic Mountain Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo pills
Arm Type
Placebo Comparator
Arm Title
Acetazolamide alone
Arm Type
Active Comparator
Arm Title
N-acetylcysteine alone
Arm Type
Active Comparator
Arm Title
Combination of N-acetylcysteine and acetazolamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
Given in gel capsules
Intervention Description
NAC 600 mg oral once daily
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Given in gel capsules
Intervention Description
Acetazolamide 250 mg oral once daily
Intervention Type
Drug
Intervention Name(s)
Placebo pills
Intervention Description
1 (or 2 in the placebo group) empty gel capsules
Primary Outcome Measure Information:
Title
Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8
Description
Spun hematocrit measured on portable machine
Time Frame
Baseline and week 8
Secondary Outcome Measure Information:
Title
Change from baseline in arterial blood gas values at week 8
Description
Analyzed using portable machine. The values analyzed include serum pH, partial pressure of carbon dioxide, partial pressure of oxygen, and serum bicarbonate.
Time Frame
Baseline and week 8
Title
Change from baseline Erythropoietin at week 8
Description
Serum hormone that stimulates red blood cell production
Time Frame
Baseline and week 8
Title
Change from baseline in serum and urine Cobalt at day 3
Description
Will calculate spot clearance of cobalt
Time Frame
Baseline and day 3
Title
Change in baseline urine protein at 8 weeks
Description
Ratio of urine total protein to urine creatinine
Time Frame
Baseline and week 8
Title
Change in baseline Chronic mountain sickness score at 8 weeks
Description
Chronic Mountain Sickness Score Absent Mild Moderate Severe Headache 0 +1 +2 +3 Dizziness 0 +1 +2 +3 Failing Memory 0 +1 +2 +3 Fatigue 0 +1 +2 +3 Breathlessness 0 +1 +2 +3 Sleep disturbances 0 +1 +2 +3 Tinnitus 0 +1 +2 +3 Anorexia 0 +1 +2 +3 Cyanosis of lips, face, or fingers 0 +1 +2 +3 Hyperemia or prominent capillaries conjunctivae or laryngopharynx 0 +1 +2 +3
Time Frame
Baseline and week 8
Title
Changes in baseline Serum electrolytes at day 3, 14 and week 8
Description
Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium < 3.0 meQ/L).
Time Frame
Baseline and Days 3, 14, and week 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Johnson, MD
Organizational Affiliation
University of Colorado Denver Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdias Hurtado, MD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Fuquay, MD
Organizational Affiliation
University of Colorado Denver Health Sciences Center
Official's Role
Study Director
Facility Information:
Facility Name
Chronic mountain sickness clinic
City
Cerro de Pasco
State/Province
Pasco
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
11844517
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.
Results Reference
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PubMed Identifier
12046023
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.
Results Reference
background
PubMed Identifier
18388356
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.
Results Reference
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Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru

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