NCT01371188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

June 9, 2011

Last Update Submit

June 9, 2011

Conditions

Lung FunctionHeart Rate VariabilityOxidative StressSystemic Inflammatory Response

Outcome Measures

Primary Outcomes (3)

  • Lung function

    Measurements of lung function in pre harvest and during harvest period

    six months

  • Heart rate variability

    To evaluate parameters of heart rate variability in pre harvest and during harvest periods

    six months

  • Oxidative stress

    Measurement of blood levels of antioxidant enzymes and malonaldehyde

    six months

Secondary Outcomes (1)

  • Environmental evaluation

    one year

Study Arms (2)

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 Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Mendonça (urban area and sugarcane plantations)

Mendonça, São Paulo, 15220-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 25229334DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 10, 2011

Study Start

December 1, 2008

Primary Completion

October 1, 2010

Study Completion

February 1, 2011

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

BR(1)