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

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ClinicalTrials.gov Identifier: NCT01187108
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : May 15, 2015
Sponsor:
Collaborators:
Universidad Peruana Cayetano Heredia
Jackson, Brian, M.S.
Thomas H Maren Foundation
Information provided by (Responsible Party):
University of Colorado, Denver

August 18, 2010
August 23, 2010
May 15, 2015
June 2013
September 2013   (Final data collection date for primary outcome measure)
Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8 [ Time Frame: Baseline and week 8 ]
Spun hematocrit measured on portable machine
Decrease in hematocrit, or fraction of plasma occupied by cellular elements [ Time Frame: Inclusion and 8 weeks ]
Spun hematocrit measured on portable machine
Complete list of historical versions of study NCT01187108 on ClinicalTrials.gov Archive Site
  • Change from baseline in arterial blood gas values at week 8 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and week 8 ]
    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 ]
    Will calculate spot clearance of cobalt
  • Change in baseline urine protein at 8 weeks [ Time Frame: Baseline and week 8 ]
    Ratio of urine total protein to urine creatinine
  • Change in baseline Chronic mountain sickness score at 8 weeks [ Time Frame: Baseline and week 8 ]
    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 ]
    Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium < 3.0 meQ/L).
  • Normalization or return toward normal values of arterial blood gas values. [ Time Frame: Inclusion and 8 weeks ]
    Analyzed using portable machine. The values analyzed include serum pH, partial pressure of carbon dioxide, partial pressure of oxygen, and serum bicarbonate.
  • Lowering of Erythropoietin, a hormone that is elevated in the presence of cobalt [ Time Frame: Inclusion and 8 weeks ]
    Serum hormone that stimulates red blood cell production
  • Cobalt in serum and urine [ Time Frame: Inclusion and day 3 ]
    Will calculate spot clearance of cobalt
  • Vascular endothelial growth factor [ Time Frame: Inclusion only ]
    Growth factor that influences angiogenesis and vasodilation
  • Urine proteinuria [ Time Frame: Inclusion and 8 weeks ]
    Ratio of urine total protein to urine creatinine
  • Chronic mountain sickness score [ Time Frame: Inclusion and 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
  • Serum electrolytes [ Time Frame: Inclusion and Days 3, 14, and 8 weeks ]
    Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium < 3.0 meQ/L).
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Erythrocytosis
  • Mountain Sickness
  • 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
  • Drug: Placebo pills
    1 (or 2 in the placebo group) empty gel capsules
  • Placebo Comparator: Placebo pills
    Intervention: Drug: Placebo pills
  • Active Comparator: Acetazolamide alone
    Interventions:
    • Drug: Acetazolamide
    • Drug: Placebo pills
  • Active Comparator: N-acetylcysteine alone
    Interventions:
    • Drug: N-acetylcysteine
    • Drug: Placebo pills
  • Active Comparator: Combination of N-acetylcysteine and acetazolamide
    Interventions:
    • Drug: N-acetylcysteine
    • Drug: Acetazolamide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
112
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
 
NCT01187108
10-0078
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
  • Universidad Peruana Cayetano Heredia
  • Jackson, Brian, M.S.
  • Thomas H Maren Foundation
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
University of Colorado, Denver
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP