Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637826
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Study on the Relationship Between Indoor Environment Use of Personal Disinfection Products and Human Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Relationship Between Indoor Environment Use of Personal Disinfection Products and Human Health
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research Purpose and Significance
Quaternary ammonium compounds QACs as cationic surfactants are widely used in disinfectants cosmetics fabric softeners hair conditioners and other personal care products They are a class of emerging organic pollutants commonly found in various environmental media Existing studies have shown that QACs exhibit immunotoxicity reproductive toxicity and developmental toxicity which has led to increasing concern in developed countries such as Europe and the United States regarding their potential health risks In 2015 the US Food and Drug Administration FDA required manufacturers to provide more human safety data when adding QACs to personal care products In 2016 the European Union banned the use of benzalkonium chloride in hand sanitizers and body washes California USA announced that it will prohibit the use of Quaternium-15 in cosmetics and personal care products starting in 2025 Currently China lacks health risk-based regulatory policies for QACs highlighting a significant gap compared to developed countries There is an urgent need to conduct detailed assessments of QAC pollution and human exposure to establish a foundation for evaluating the health risks associated with QACs
In summary investigating QAC pollution and human exposure in indoor environments is critical for understanding their health risks and will provide important theoretical support for establishing environmental health standards for QACs in China
Research Methods
1 Participant Recruitment
This study will adopt a panel study design recruiting 80 young student volunteers from an existing cohort
2 Study Design
Participants will be randomly assigned to two groups in a randomized crossover trial Group A will use quaternary ammonium compound QAC disinfectant products including laundry disinfectant hand sanitizing wipes and surface and floor disinfecting wipes while Group B will use alcohol-based disinfectant products both for a period of one month After the first intervention there will be a one-month washout period followed by a crossover intervention where the groups switch products for another month Participants will wear a custom environmental monitoring device according to the guidelines and will regularly complete health questionnaires functional assessments and biological sample collections
3 Exposure Measurement
External exposure to organic compounds in the environment will be monitored using silicone wristbands while internal exposure will be assessed using blood and urine samples
4 Health Indicator Measurement
A combination of health scales and biochemical tests will be used to assess related health indicators Health measurements will be conducted four times-once before and once after each intervention Each session will include the following a health questionnaire 10 mL of fasting blood 40 mL of morning urine cognitive tests EEG tests near-infrared brain imaging respiratory metabolic tests arterial function tests and body composition tests
5 Statistical Analysis
Mixed-effects models and machine learning algorithms will be employed to assess the health effects of QAC and alcohol-based disinfectant products on the human body
Quaternary ammonium compounds QACs as cationic surfactants are widely used in disinfectants cosmetics fabric softeners hair conditioners and other personal care products They are a class of emerging organic pollutants commonly found in various environmental media Existing studies have shown that QACs exhibit immunotoxicity reproductive toxicity and developmental toxicity which has led to increasing concern in developed countries such as Europe and the United States regarding their potential health risks In 2015 the US Food and Drug Administration FDA required manufacturers to provide more human safety data when adding QACs to personal care products In 2016 the European Union banned the use of benzalkonium chloride in hand sanitizers and body washes California USA announced that it will prohibit the use of Quaternium-15 in cosmetics and personal care products starting in 2025 Currently China lacks health risk-based regulatory policies for QACs highlighting a significant gap compared to developed countries There is an urgent need to conduct detailed assessments of QAC pollution and human exposure to establish a foundation for evaluating the health risks associated with QACs
In summary investigating QAC pollution and human exposure in indoor environments is critical for understanding their health risks and will provide important theoretical support for establishing environmental health standards for QACs in China
Research Methods
1 Participant Recruitment
This study will adopt a panel study design recruiting 80 young student volunteers from an existing cohort
2 Study Design
Participants will be randomly assigned to two groups in a randomized crossover trial Group A will use quaternary ammonium compound QAC disinfectant products including laundry disinfectant hand sanitizing wipes and surface and floor disinfecting wipes while Group B will use alcohol-based disinfectant products both for a period of one month After the first intervention there will be a one-month washout period followed by a crossover intervention where the groups switch products for another month Participants will wear a custom environmental monitoring device according to the guidelines and will regularly complete health questionnaires functional assessments and biological sample collections
3 Exposure Measurement
External exposure to organic compounds in the environment will be monitored using silicone wristbands while internal exposure will be assessed using blood and urine samples
4 Health Indicator Measurement
A combination of health scales and biochemical tests will be used to assess related health indicators Health measurements will be conducted four times-once before and once after each intervention Each session will include the following a health questionnaire 10 mL of fasting blood 40 mL of morning urine cognitive tests EEG tests near-infrared brain imaging respiratory metabolic tests arterial function tests and body composition tests
5 Statistical Analysis
Mixed-effects models and machine learning algorithms will be employed to assess the health effects of QAC and alcohol-based disinfectant products on the human body
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None