Viewing Study NCT00014963



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Study NCT ID: NCT00014963
Status: COMPLETED
Last Update Posted: 2006-03-23
First Post: 2001-04-16

Brief Title: Biomarkers of Benzene Exposure in Inner City Residents
Sponsor: National Institute of Environmental Health Sciences NIEHS
Organization: National Institute of Environmental Health Sciences NIEHS

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2006-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 13-butadiene and carbon tetrachloride will be performed Two urinary biomarkers for benzene exposure transtrans-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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None