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OpenTrials
Completed

NCT Number: NCT01371188

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

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.

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Key information

Conditions

Lung Function Heart Rate Variability Oxidative Stress Systemic Inflammatory Response

Age range

20 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

City of Mendonça (urban area and sugarcane plantations)

Mendonça, São Paulo, 15220-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Environmental evaluation

    Time frame: one year

    Measurement of athmospheric concentration of particulate matter.

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 10, 2011
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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