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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Erythrocytosis Mountain Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo pills

Group Type PLACEBO_COMPARATOR

Placebo pills

Intervention Type DRUG

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

Acetazolamide alone

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

Acetazolamide 250 mg oral once daily

Placebo pills

Intervention Type DRUG

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

N-acetylcysteine alone

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

NAC 600 mg oral once daily

Placebo pills

Intervention Type DRUG

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

Combination of N-acetylcysteine and acetazolamide

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

NAC 600 mg oral once daily

Acetazolamide

Intervention Type DRUG

Acetazolamide 250 mg oral once daily

Interventions

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N-acetylcysteine

NAC 600 mg oral once daily

Intervention Type DRUG

Acetazolamide

Acetazolamide 250 mg oral once daily

Intervention Type DRUG

Placebo pills

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

Intervention Type DRUG

Other Intervention Names

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Given in gel capsules Given in gel capsules

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No