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This study has been withdrawn prior to enrollment.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: August 20, 2013
Last verified: December 2012
  Purpose

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.


Condition Phase
Bisphenol A
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: BPA Biomonitoring Study in Cashiers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287169

Sponsors and Collaborators
Investigators
Principal Investigator: John Bucher, Ph.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01287169     History of Changes
Other Study ID Numbers: 999911074, 11-E-N074
Study First Received: January 29, 2011
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bisphenol A

ClinicalTrials.gov processed this record on July 23, 2014