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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371188
• Other study ID #: Mendonca
• Secondary ID: 402195/2008
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 9, 2011
• Start date: December 2008
• Est. completion date: February 2011

Study information

• Verified date: June 2011
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Rate Variability
• Lung Function
• Oxidative Stress
• Systemic Inflammatory Response

Locations

Country	Name	City	State
Brazil	City of Mendonça (urban area and sugarcane plantations)	Mendonça	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
InCor Heart Institute	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function	Measurements of lung function in pre harvest and during harvest period	six months	No
Primary	Heart rate variability	To evaluate parameters of heart rate variability in pre harvest and during harvest periods	six months	No
Primary	Oxidative stress	Measurement of blood levels of antioxidant enzymes and malonaldehyde	six months	No
Secondary	Environmental evaluation	Measurement of athmospheric concentration of particulate matter.	one year	No