Bisphenol A Controlled Exposure Study
- Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA.
- To study controlled exposure to BPA and its effects on the body.
- Healthy, non-obese volunteers between 25 and 45 years of age.
- Participants will have five visits over about 2 to 4 weeks for this study.
- At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period.
- The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit.
- Participants will have three follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Bisphenol A (BPA) Pharmacokinetic (PK): Controlled Exposure Study|
- Pharmacokinetics of d-BPA and d-BPA conjugates in blood and urine over 5 days.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573429
|Contact: Lisa B Murphy, MEd||(919) firstname.lastname@example.org|
|Contact: Shepherd H Schurman, M.D.||(919) email@example.com|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)||Recruiting|
|Research Triangle Park, North Carolina, United States|
|Contact: Lisa Murphy 919-541-9839 firstname.lastname@example.org|
|Principal Investigator:||Shepherd H Schurman, M.D.||National Institute of Environmental Health Sciences (NIEHS)|