Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Peruana Cayetano Heredia | OTHER |
| Jackson, Brian, M.S. | INDIV |
| Thomas H Maren Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pills | Placebo Comparator |
| |
| Acetazolamide alone | Active Comparator |
| |
| N-acetylcysteine alone | Active Comparator |
| |
| Combination of N-acetylcysteine and acetazolamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | NAC 600 mg oral once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8 | Spun hematocrit measured on portable machine | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 8 |
| Change from baseline Erythropoietin at week 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Johnson, MD | University of Colorado Denver Health Sciences Center | Principal Investigator |
| Abdias Hurtado, MD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Richard Fuquay, MD | University of Colorado Denver Health Sciences Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic mountain sickness clinic | Cerro de Pasco | Departamento de Pasco | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11844517 | Background | 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. | |
| 12046023 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011086 | Polycythemia |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D005782 | Gels |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acetazolamide | Drug | Acetazolamide 250 mg oral once daily |
|
|
| Placebo pills | Drug | 1 (or 2 in the placebo group) empty gel capsules |
|
Serum hormone that stimulates red blood cell production |
| Baseline and week 8 |
| Change from baseline in serum and urine Cobalt at day 3 | Will calculate spot clearance of cobalt | Baseline and day 3 |
| Change in baseline urine protein at 8 weeks | Ratio of urine total protein to urine creatinine | Baseline and week 8 |
| 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 | Baseline and week 8 |
| 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). | Baseline and Days 3, 14, and week 8 |
| 18388356 | Background | 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. |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |