Study of Exposure to Chemicals in Consumer Products
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|ClinicalTrials.gov Identifier: NCT02471365|
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : February 17, 2020
- 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 (e.g., surveys and models) measure exposure to chemicals in personal care and household products.
- To test and improve the ways that studies gather data about contact with chemicals found in consumer products.
- Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.
- 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 <TAB>photograph 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.
|Condition or disease|
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 U.S. 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 (e.g., 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 use/marketing databases
- Evaluate prediction models
- Characterize behavior that impact exposures using new technologies (iPad/internet use)
Personal care products (PCPs) and other household/consumer 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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||NIEHS EPA Pilot Study of Exposure to Chemicals in Consumer Products|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Non-pregnant and non-nursing females between 35 and 74 who usesa high number (e.g., 15 or more products a day) of consumer products.
- Primary endpoint will be daily individual exposure estimates for each participant calculated through forward modeling of questionnaire data and environmental measurements and reverse modeling ofbiomarker data. [ Time Frame: Ongoing ]
- To evaluate the accuracy of historical consumer product usage questionnaires. [ Time Frame: Ongoing ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471365
|Contact: Kyla W Taylor, Ph.D.||(919) firstname.lastname@example.org|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)||Recruiting|
|Research Triangle Park, North Carolina, United States, 27713|
|Contact: Kyla Taylor, Ph.D. 919-316-4707 email@example.com|
|Principal Investigator:||Kyla W Taylor, Ph.D.||National Institute of Environmental Health Sciences (NIEHS)|