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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:
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
  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:

MedlinePlus related topics: Air Pollution Burns
U.S. FDA Resources

Further study details as provided by InCor Heart Institute:

Primary Outcome Measures:
  • Lung function [ Time Frame: six months ] [ Designated as safety issue: No ]
    Measurements of lung function in pre harvest and during harvest period

  • Heart rate variability [ Time Frame: six months ] [ Designated as safety issue: No ]
    To evaluate parameters of heart rate variability in pre harvest and during harvest periods

  • Oxidative stress [ Time Frame: six months ] [ Designated as safety issue: No ]
    Measurement of blood levels of antioxidant enzymes and malonaldehyde


Secondary Outcome Measures:
  • Environmental evaluation [ Time Frame: one year ] [ Designated as safety issue: No ]
    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)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 
Study First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on September 26, 2016