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

NCT01187108 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2015-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

N-acetylcysteine

NAC 600 mg oral once daily

DRUG

Acetazolamide

Acetazolamide 250 mg oral once daily

DRUG

Placebo pills

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

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    collaborator OTHER

  • Jackson, Brian, M.S.

    collaborator INDIV

  • Thomas H Maren Foundation

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Richard Johnson, MD · University of Colorado Denver Health Sciences Center

  • Abdias Hurtado, MD · Universidad Peruana Cayetano Heredia

  • Richard Fuquay, MD · University of Colorado Denver Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01187108 on ClinicalTrials.gov