BPA Biomonitoring Study in Cashiers

Bisphenol A Clinical Trial

Official title:

BPA Biomonitoring Study in Cashiers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01287169
• Other study ID #: 999911074
• Secondary ID: 11-E-N074
• Status: Withdrawn
• Start date: January 10, 2011
• Est. completion date: December 4, 2012

Study information

• Verified date: December 4, 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 4, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Bisphenol A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

References & Publications (3)

Biedermann S, Tschudin P, Grob K. Transfer of bisphenol A from thermal printer paper to the skin. Anal Bioanal Chem. 2010 Sep;398(1):571-6. doi: 10.1007/s00216-010-3936-9. Epub 2010 Jul 11. — View Citation

Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Environ Health Perspect. 2008 Jan;116(1):39-44. doi: 10.1289/ehp.10753. — View Citation

Kang JH, Kondo F, Katayama Y. Human exposure to bisphenol A. Toxicology. 2006 Sep 21;226(2-3):79-89. Epub 2006 Jun 16. Review. — View Citation