Erythrocytosis, Mountain Sickness
Conditions
Keywords
Cobalt, Excessive Erythrocytosis, Monge's Disease, Acetazolamide, N-acetylcysteine, Altitude Sickness, 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.
Interventions
DRUGN-acetylcysteine
NAC 600 mg oral once daily
DRUGAcetazolamide
Acetazolamide 250 mg oral once daily
DRUGPlacebo pills
1 (or 2 in the placebo group) empty gel capsules
Sponsors
Universidad Peruana Cayetano Heredia
Jackson, Brian, M.S.
Thomas H Maren Foundation
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8 | Baseline and week 8 | Spun hematocrit measured on portable machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in arterial blood gas values at week 8 | 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 | Baseline and week 8 | Serum hormone that stimulates red blood cell production |
| Change from baseline in serum and urine Cobalt at day 3 | Baseline and day 3 | Will calculate spot clearance of cobalt |
| Change in baseline urine protein at 8 weeks | Baseline and week 8 | Ratio of urine total protein to urine creatinine |
| Change in baseline Chronic mountain sickness score at 8 weeks | 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 | Baseline and Days 3, 14, and week 8 | Electrolytes, specifically monitoring serum potassium to treat serious hypokalemia (serum potassium \< 3.0 meQ/L). |
Countries
Peru
Outcome results
None listed