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

This study is not yet open for participant recruitment.
Verified October 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
Thomas H Maren Foundation
Abdias Hurtado, MD and Elizabeth Escudero, MD (Universidad Peruana Cayetano Heredia)
Jackson, Brian, M.S.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01187108
First received: August 18, 2010
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Erythrocytosis
Mountain Sickness
 Drug: N-acetylcysteine
Drug: Acetazolamide
Drug: Placebo pills
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    Spun hematocrit measured on portable machine


Secondary Outcome Measures:
  • Change from baseline in arterial blood gas values at week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    Serum hormone that stimulates red blood cell production

  • Change from baseline in serum and urine Cobalt at day 3 [ Time Frame: Baseline and day 3 ] [ Designated as safety issue: No ]
    Will calculate spot clearance of cobalt

  • Change in baseline urine protein at 8 weeks [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
    Ratio of urine total protein to urine creatinine

  • Change in baseline Chronic mountain sickness score at 8 weeks [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and Days 3, 14, and week 8 ] [ Designated as safety issue: Yes ]
    Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium < 3.0 meQ/L).


Estimated Enrollment: 112
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pills Drug: Placebo pills
1 (or 2 in the placebo group) empty gel capsules
Active Comparator: Acetazolamide alone Drug: Acetazolamide
Acetazolamide 250 mg oral once daily
Other Name: Given in gel capsules
Drug: Placebo pills
1 (or 2 in the placebo group) empty gel capsules
Active Comparator: N-acetylcysteine alone Drug: N-acetylcysteine
NAC 600 mg oral once daily
Other Name: Given in gel capsules
Drug: Placebo pills
1 (or 2 in the placebo group) empty gel capsules
Active Comparator: Combination of N-acetylcysteine and acetazolamide Drug: N-acetylcysteine
NAC 600 mg oral once daily
Other Name: Given in gel capsules
Drug: Acetazolamide
Acetazolamide 250 mg oral once daily
Other Name: Given in gel capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187108

Contacts
Contact: Abdias Hurtado, MD 0511 2248178 ahurtado@upch.edu.pe
Contact: Elizabeth Escudero, MD 0511 3656900 elizabethescudero1908@yahoo.es

Locations
Peru
Chronic mountain sickness clinic Not yet recruiting
Cerro de Pasco, Pasco, Peru
Sponsors and Collaborators
University of Colorado, Denver
Thomas H Maren Foundation
Abdias Hurtado, MD and Elizabeth Escudero, MD (Universidad Peruana Cayetano Heredia)
Jackson, Brian, M.S.
Investigators
Principal Investigator: Richard Johnson, MD University of Colorado Denver Health Sciences Center
Principal Investigator: Abdias Hurtado, MD Universidad Peruana Cayetano Heredia
Study Director: Richard Fuquay, MD University of Colorado Denver Health Sciences Center
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01187108     History of Changes
Other Study ID Numbers: 10-0078
Study First Received: August 18, 2010
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board
Peru: Universidad Peruana Cayetano Heredia

Keywords provided by University of Colorado, Denver:
Cobalt
Excessive Erythrocytosis
Monge's Disease
Acetazolamide
 N-acetylcysteine
Altitude Sickness
Chronic Mountain Sickness

Additional relevant MeSH terms:
Altitude Sickness
Polycythemia
Respiration Disorders
Respiratory Tract Diseases
Hematologic Diseases
Acetazolamide
Acetylcysteine
N-monoacetylcystine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013