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NCT01573429 · ClinicalTrials.gov registry record · Phase 1
Bisphenol A Controlled Exposure Study
A Phase 1 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01573429 is a Phase 1 study that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 38 participants.
The verdict
NCT01573429, a Phase 1 study, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Background: \- 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. Objectives: \- To study controlled exposure to BPA and its effects on the body. Eligibility: \- Healthy, non-obese volunteers between 25 and 45 years of age. Design: * Participants will have six 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 four 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....
Interventions
- OTHER deuterated-Bisphenol A (d-BPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-07-18 |
| Est. Completion | 2020-06-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01573429
The ClinicalTrials.gov registry entry for NCT01573429 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which deuterated-Bisphenol A (d-BPA) is the first listed.
NCT01573429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01573429 about?
NCT01573429 is a clinical study titled "Bisphenol A Controlled Exposure Study". Background: \- 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 kn...
What is the current status of trial NCT01573429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-07-18. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT01573429?
The interventions under investigation include: deuterated-Bisphenol A (d-BPA) (OTHER).
Who is sponsoring clinical trial NCT01573429?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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