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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00014963
Other study ID # 7780-CP-001
Secondary ID
Status Completed
Phase N/A
First received April 16, 2001
Last updated March 22, 2006

Study information

Verified date March 2006
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years and older
Eligibility residence in one of the study communities

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins University School of Hygiene and Public Health Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS) Environmental Protection Agency (EPA), Mickey Leland National Urban Air Toxics Research Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Weaver VM, Buckley TJ, Groopman JD. Approaches to environmental exposure assessment in children. Environ Health Perspect. 1998 Jun;106 Suppl 3:827-32. Review. — View Citation

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. — View Citation

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