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BPA Biomonitoring Study in Cashiers

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01287169
First received: January 29, 2011
Last updated: May 3, 2013
Last verified: December 2012
History of Changes

January 29, 2011
May 3, 2013
January 2011
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Complete list of historical versions of study NCT01287169 on ClinicalTrials.gov Archive Site
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BPA Biomonitoring Study in Cashiers
BPA Biomonitoring Study in Cashiers

We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.

We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.
Observational
Time Perspective: Prospective
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Bisphenol A
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
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  • INCLUSION CRITERIA:
  • Male or female 18 years of age or older at the time of enrollment
  • Employed as a cashier at the site location
  • Anticipate continued employment at this business for the duration of both phases of the study
  • Able to understand and provide written informed consent to participate in the study
  • Have a minimum of 24 hours off from work before providing pre-shift samples
  • Participants may be healthy or have preexisting conditions.

Field Site Inclusion Criteria:

  • Have a minimum of 20 employed cashiers
  • Use BPA-laden thermal paper and is planning to switch to BPA-free thermal paper
  • Have a private area that the study nurse can use for enrollment and collection of biological samples
  • Willing to collaborate with study team to conduct study on-site

EXCLUSION CRITERIA:

-There are no additional exclusion criteria
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01287169
999911074, 11-E-N074
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National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Darryl C Zeldin, M.D. National Institute of Environmental Health Sciences (NIEHS)
National Institutes of Health Clinical Center (CC)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP