- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014963
Biomarkers of Benzene Exposure in Inner City Residents
March 22, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby.
Parents and children as well as adults alone will be included.
Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured.
Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products.
Benzene air and urine exposure measurements will be compared in each community as well as between communities.
By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution.
Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.
Study Overview
Status
Completed
Conditions
Detailed Description
The current study focuses on an environmental exposure assessment of a South Baltimore community residing near a heavily industrialized area.
Exposure differences between this community and a reference community that is demographically similar to South Baltimore but has limited industrial impact will be assessed.
Participants will include both parent child study pairs and adults.
Outdoor, indoor and personal 72 hour badge monitoring for benzene, 1,3-butadiene and carbon tetrachloride will be performed.
Two urinary biomarkers for benzene exposure, trans,trans-muconic acid (ttMA) and s-phenylmercapturic acid (S-PMA) will be measured at 3 daily time points over the 3 day period.
Past work indicates that ingestion of sorbate preserved foods causes substantial interference with the benzene biomarker, ttMA.
Therefore, participants will restrict their intake of sorbate preserved foods during the study.
On the day of greatest dietary restriction, a 24 hour benzene personal air measurement will be obtained.
Data analysis will include correlations of benzene badge exposure measurements and urinary biomarkers.
Air and biomarker benzene exposure data will be compared between communities.
Linear regression modeling will be used to determine important explanatory factors of the biomarkers.
The inclusion of parent child study pairs will also allow correlation of benzene air levels and urinary biomarkers between parents and children.
This will provide exposure information on a potentially susceptible subpopulation, e.g.
children, and allow assessment of potential for age-related differences in benzene metabolism.
Finally, we will be able to determine if dietary restriction is practical and results in greater specificity of ttMA as a benzene biomarker.
Study Type
Observational
Enrollment
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Hygiene and Public Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
residence in one of the study communities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Weaver VM, Buckley TJ, Groopman JD. Approaches to environmental exposure assessment in children. Environ Health Perspect. 1998 Jun;106 Suppl 3(Suppl 3):827-32. doi: 10.1289/ehp.98106827.
- Weaver VM, Davoli CT, Heller PJ, Fitzwilliam A, Peters HL, Sunyer J, Murphy SE, Goldstein GW, Groopman JD. Benzene exposure, assessed by urinary trans,trans-muconic acid, in urban children with elevated blood lead levels. Environ Health Perspect. 1996 Mar;104(3):318-23. doi: 10.1289/ehp.96104318.
- Weaver VM, Buckley T, Groopman JD. Lack of specificity of trans,trans-muconic acid as a benzene biomarker after ingestion of sorbic acid-preserved foods. Cancer Epidemiol Biomarkers Prev. 2000 Jul;9(7):749-55.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 16, 2001
First Submitted That Met QC Criteria
April 17, 2001
First Posted (Estimate)
April 18, 2001
Study Record Updates
Last Update Posted (Estimate)
March 23, 2006
Last Update Submitted That Met QC Criteria
March 22, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7780-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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