Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02471365
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2015-06-12
Brief Title:
Study of Exposure to Chemicals in Consumer Products
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
NIEHS EPA Pilot Study of Exposure to Chemicals in Consumer Products
Status:
COMPLETED
Status Verified Date:
2024-06-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- In a lifetime a person may encounter tens of thousands of chemicals used as ingredients in the products they buy It s not easy to measure them because the companies that sell the products don t have to tell the exact chemical ingredients Researchers want to compare how existing methods eg surveys and models measure exposure to chemicals in personal care and household products
Objective
- To test and improve the ways that studies gather data about contact with chemicals found in consumer products
Eligibility
- Healthy women volunteers ages 35 74 who use at least 15 consumer products a day
Design
Participants will be screened with medical history pregnancy test smoking test and blood sample They will answer questions about their homes and products they use
Participation will last about 30 hours over 12 days
Researchers will
Place air samplers inside and outside participants homes for 10 days One sampler will need to be plugged into an electrical outlet It will make a low continuous sound while in operation
Collect house dust samples and record all consumer products in the house
Visit the house daily to collect samples
Participants will
Give a blood sample at a clinic twice
Collect all urine voids for 10 days They will label it and put it in a special cooler
Wear 4 small devices that measure air pollution chemicals location and activity
Record what they eat and what consumer products they use They will write these in a diary and TABphotograph them on an iPhone provided to them
On day 2 of the study they will collect a duplicate sample of what they eat
Take iPhone videos of their use of certain products
Answer questions about chemical ingredients in their personal care products
- In a lifetime a person may encounter tens of thousands of chemicals used as ingredients in the products they buy It s not easy to measure them because the companies that sell the products don t have to tell the exact chemical ingredients Researchers want to compare how existing methods eg surveys and models measure exposure to chemicals in personal care and household products
Objective
- To test and improve the ways that studies gather data about contact with chemicals found in consumer products
Eligibility
- Healthy women volunteers ages 35 74 who use at least 15 consumer products a day
Design
Participants will be screened with medical history pregnancy test smoking test and blood sample They will answer questions about their homes and products they use
Participation will last about 30 hours over 12 days
Researchers will
Place air samplers inside and outside participants homes for 10 days One sampler will need to be plugged into an electrical outlet It will make a low continuous sound while in operation
Collect house dust samples and record all consumer products in the house
Visit the house daily to collect samples
Participants will
Give a blood sample at a clinic twice
Collect all urine voids for 10 days They will label it and put it in a special cooler
Wear 4 small devices that measure air pollution chemicals location and activity
Record what they eat and what consumer products they use They will write these in a diary and TABphotograph them on an iPhone provided to them
On day 2 of the study they will collect a duplicate sample of what they eat
Take iPhone videos of their use of certain products
Answer questions about chemical ingredients in their personal care products
Detailed Description:
Research to advance the characterization of environmental and chemical exposures through improved exposure assessments at both the individual and population levels is a research priority identified in the Strategic Research Action Plan for the US Environmental Protection Agency EPA s Chemical Safety for Sustainability CSS program EPA 2012 and the National Institutes of Environmental Health Sciences NIEHS Strategic Plan for 2012-2017 NIEHS 2012 Leading up to the Strategic Plan specific research priorities related to exposure assessment were identified in the 2011 NIEHS workshop Advancing Research on Mixtures New Perspectives and Approaches for Predicting Adverse Human Health Effects
including the need to evaluate the utility of existing instruments that classify or quantify exposures develop better tools to improve exposure assessment and to better understand the nature of combined exposures eg mixtures This project will inform research priorities identified in the NIEHS strategic plan and several specific research needs discussed during the 2011 NIEHS workshop on mixtures with a focus on assessing exposures from personal care and household products
Evaluate current exposure assessment technologies including questionnaires
Develop better models that link source with behavior to predict exposure
Analyze combined exposures
Evaluate usefulness of commercially available product usemarketing databases
Evaluate prediction models
Characterize behavior that impact exposures using new technologies iPadinternet use
Personal care products PCPs and other householdconsumer products are of particular interest because of the efficiency of their delivery and widespread use Exposure to chemicals in PCPs can result through either direct or indirect routes of contact depending on the use of the product Dodson 2012 Koniecki et al 2011 Rudel et al 2003 Schettler 2006 Weschler and Nazaroff 2014 Health concerns exist about some chemicals found in PCPs and household setting Over the course of a lifetime the average consumer may encounter tens of thousands of chemicals used as ingredients in consumer products many of which are proprietary thus getting a complete picture of the human exposome is challenging Given the large number of co-occurring chemicals in these products new strategies tools and
techniques need to be developed and evaluated for their utility in assessing exposure to the multitude tens of thousands of chemicals representing the reality of exposure Innovative tools need to be evaluated for their potential contributions to exposure assessment through rapid cost-efficient methods which allow the simultaneous measurement of multiple chemical agents and gathering of contextual information to inform exposure reduction These integrated tools and techniques can then be used to refine measurement and predictive modeling methods that support high throughput chemical analysis and exposure assessment
The proposed research concept represents collaboration between NIEHS Division of the National Toxicology Program Division of Intramural Research and the Clinical Research Unit and the EPA Office ofResearch and Development ORD The partnership includes co- funding with EPA the sharing of equipment and expertise and the use of EPA field teams for extensive collection of exposure information
including the need to evaluate the utility of existing instruments that classify or quantify exposures develop better tools to improve exposure assessment and to better understand the nature of combined exposures eg mixtures This project will inform research priorities identified in the NIEHS strategic plan and several specific research needs discussed during the 2011 NIEHS workshop on mixtures with a focus on assessing exposures from personal care and household products
Evaluate current exposure assessment technologies including questionnaires
Develop better models that link source with behavior to predict exposure
Analyze combined exposures
Evaluate usefulness of commercially available product usemarketing databases
Evaluate prediction models
Characterize behavior that impact exposures using new technologies iPadinternet use
Personal care products PCPs and other householdconsumer products are of particular interest because of the efficiency of their delivery and widespread use Exposure to chemicals in PCPs can result through either direct or indirect routes of contact depending on the use of the product Dodson 2012 Koniecki et al 2011 Rudel et al 2003 Schettler 2006 Weschler and Nazaroff 2014 Health concerns exist about some chemicals found in PCPs and household setting Over the course of a lifetime the average consumer may encounter tens of thousands of chemicals used as ingredients in consumer products many of which are proprietary thus getting a complete picture of the human exposome is challenging Given the large number of co-occurring chemicals in these products new strategies tools and
techniques need to be developed and evaluated for their utility in assessing exposure to the multitude tens of thousands of chemicals representing the reality of exposure Innovative tools need to be evaluated for their potential contributions to exposure assessment through rapid cost-efficient methods which allow the simultaneous measurement of multiple chemical agents and gathering of contextual information to inform exposure reduction These integrated tools and techniques can then be used to refine measurement and predictive modeling methods that support high throughput chemical analysis and exposure assessment
The proposed research concept represents collaboration between NIEHS Division of the National Toxicology Program Division of Intramural Research and the Clinical Research Unit and the EPA Office ofResearch and Development ORD The partnership includes co- funding with EPA the sharing of equipment and expertise and the use of EPA field teams for extensive collection of exposure information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-E-0134 | None | None | None |