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Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers
This study has been completed.
Sponsor:
InCor Heart Institute
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT01371188
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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Purpose
Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and prevalent professional activity of agribusiness segment of the Brazilian economy, exposes workers and people of neighboring towns to high concentrations of pollutants and, therefore, potentially several risks to health hazards.
Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers and volunteers from a nearby town in non-harvest and harvest periods.
| Condition |
|---|
| Lung Function Heart Rate Variability Oxidative Stress Systemic Inflammatory Response |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Effects of Exposure to Outdoor Air Pollution From Biomass Burning on Lung Function, Heart Rate Variability and Systemic Inflammatory Blood Markers in Sugarcane Workers |
Resource links provided by NLM:
Further study details as provided by InCor Heart Institute:
Primary Outcome Measures:
- Lung function [ Time Frame: six months ]Measurements of lung function in pre harvest and during harvest period
- Heart rate variability [ Time Frame: six months ]To evaluate parameters of heart rate variability in pre harvest and during harvest periods
- Oxidative stress [ Time Frame: six months ]Measurement of blood levels of antioxidant enzymes and malonaldehyde
Secondary Outcome Measures:
- Environmental evaluation [ Time Frame: one year ]Measurement of athmospheric concentration of particulate matter.
Biospecimen Retention: Samples With DNA
Whole blood.
| Enrollment: | 222 |
| Study Start Date: | December 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Controls
Healthy male volunteers, non-smokers, 20-40yo, living in the city of Mendonça, São Paulo-Brazil.
|
|
Sugarcane Workers
Healthy male volunteers, non-smokers, 20-40yo, sugarcane workers, living in the city of Mendonça, São Paulo-Brazil.
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Population from the city of Mendonça, São Paulo-Brazil, divided into the following groups: sugarcane workers (those who work in sugarcane plantations) and controls (healthy volunteers from the same city)
Criteria
Inclusion Criteria:
- The criteria for inclusion in the study were: age between 20 and 40 years, male gender and being non-smokers (or former-smokers for at least a year and a smoking history of less than 20 pack-years).
Exclusion Criteria:
- Exclusion criteria were history of cardiovascular or respiratory disease, the use of bronchodilator, non-steroidal anti-inflammatory drugs, anticoagulants or antiplatelet drugs and statins.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01371188
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371188
Locations
| Brazil | |
| City of Mendonça (urban area and sugarcane plantations) | |
| Mendonça, Sao Paulo, Brazil, 15220-000 | |
Sponsors and Collaborators
InCor Heart Institute
Conselho Nacional de Desenvolvimento Científico e Tecnológico
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Ubiratan de Paula Santos and Dr. Gustavo Faibischew Prado, InCor |
| ClinicalTrials.gov Identifier: | NCT01371188 History of Changes |
| Other Study ID Numbers: |
Mendonca 402195/2008 ( Other Identifier: CNPQ ) |
| Study First Received: | June 9, 2011 |
| Last Updated: | June 9, 2011 |
ClinicalTrials.gov processed this record on July 24, 2017