Skip to main content
OpenTrials
Completed

NCT Number: NCT01187108

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erythrocytosis Altitude Sickness Hematologic Diseases Hemic and Lymphatic Diseases Mountain Sickness Polycythemia Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chronic mountain sickness clinic

Cerro de Pasco, Departamento de Pasco, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

NAC 600 mg oral once daily

Other names: Given in gel capsules

Acetazolamide

Drug

Acetazolamide 250 mg oral once daily

Other names: Given in gel capsules

Placebo pills

Drug

1 (or 2 in the placebo group) empty gel capsules

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Change from baseline Erythropoietin at week 8

    Time frame: Baseline and week 8

    Serum hormone that stimulates red blood cell production

  3. Change from baseline in serum and urine Cobalt at day 3

    Time frame: Baseline and day 3

    Will calculate spot clearance of cobalt

  4. Change in baseline urine protein at 8 weeks

    Time frame: Baseline and week 8

    Ratio of urine total protein to urine creatinine

  5. 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

  6. 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Jackson, Brian, M.S.
  • Thomas H Maren Foundation
  • Universidad Peruana Cayetano Heredia

Registry information

Official study title

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

Acronym: CoCMS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.