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Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371188
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Information provided by:

Study Description
Brief Summary:

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 or disease
Lung Function Heart Rate Variability Oxidative Stress Systemic Inflammatory Response

Study Design

Study Type : Observational
Actual Enrollment : 222 participants
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
Study Start Date : December 2008
Primary Completion Date : October 2010
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :
  1. Lung function [ Time Frame: six months ]
    Measurements of lung function in pre harvest and during harvest period

  2. Heart rate variability [ Time Frame: six months ]
    To evaluate parameters of heart rate variability in pre harvest and during harvest periods

  3. Oxidative stress [ Time Frame: six months ]
    Measurement of blood levels of antioxidant enzymes and malonaldehyde

Secondary Outcome Measures :
  1. Environmental evaluation [ Time Frame: one year ]
    Measurement of athmospheric concentration of particulate matter.

Biospecimen Retention:   Samples With DNA
Whole blood.

Eligibility Criteria

Information from the National Library of Medicine

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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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371188

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 )
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011