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

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ClinicalTrials.gov Identifier: NCT01371188
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
InCor Heart Institute

Tracking Information
First Submitted Date June 9, 2011
First Posted Date June 10, 2011
Last Update Posted Date June 10, 2011
Study Start Date December 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2011)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 9, 2011)
Environmental evaluation [ Time Frame: one year ]
Measurement of athmospheric concentration of particulate matter.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood.
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)
Condition
  • Lung Function
  • Heart Rate Variability
  • Oxidative Stress
  • Systemic Inflammatory Response
Intervention Not Provided
Study 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.
Publications * Paula Santos U, Zanetta DM, Terra-Filho M, Burdmann EA. Burnt sugarcane harvesting is associated with acute renal dysfunction. Kidney Int. 2015 Apr;87(4):792-9. doi: 10.1038/ki.2014.306. Epub 2014 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2011)
222
Original Actual Enrollment Same as current
Actual Study Completion Date February 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01371188
Other Study ID Numbers Mendonca
402195/2008 ( Other Identifier: CNPQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Dr Ubiratan de Paula Santos and Dr. Gustavo Faibischew Prado, InCor
Original Responsible Party Same as current
Current Study Sponsor InCor Heart Institute
Original Study Sponsor Same as current
Collaborators Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators Not Provided
PRS Account InCor Heart Institute
Verification Date June 2011