Clinical Trial: Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness

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.

Detailed Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome: Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8 [ Time Frame: Baseline and week 8 ]

Original Primary Outcome: Decrease in hematocrit, or fraction of plasma occupied by cellular elements [ Time Frame: Inclusion and 8 weeks ]

Current Secondary Outcome:

• 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).

Original Secondary Outcome:

• 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).

Information By: University of Colorado, Denver

Dates:
Date Received: August 18, 2010
Date Started: June 2013
Date Completion:
Last Updated: May 13, 2015
Last Verified: May 2015