Study on the Relationship Between Indoor Environment, Use of Personal Disinfection Products, and Human Health

NCT06637826 | Recruiting Early Phase 1

• 1 other identifier: SYSU_SPHSZ_2024099
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 U.S. 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. 1.Participant Recruitment:
2. 2.Study Design:
3. 3.Exposure Measurement:
4. 4.Health Indicator Measurement:
5. 5.Statistical Analysis:

Conditions

Healthy

Keywords

Quaternary Ammonium Disinfectants; Disinfectants; Indoor Environment; Human Health

Outcome Measures

Primary Outcomes (1)

• 64 Participants with Disinfectant Products-Related Adverse Events

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Blank Control Group

NO INTERVENTION

Disinfectant Use Control Group

EXPERIMENTAL

Behavioral: Quaternary Ammonium Compound Disinfectants; Behavioral: Alcohol-based Disinfectants

Interventions

Quaternary Ammonium Compound Disinfectants BEHAVIORAL

Participants are instructed to use quaternary ammonium compound disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include: * Laundry disinfectant: Use at least twice per week. * Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals. * Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks. * Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor. After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation.

Disinfectant Use Control Group

Alcohol-based Disinfectants BEHAVIORAL

Participants are instructed to use alcohol-based disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include: * Laundry disinfectant: Use at least twice per week. * Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals. * Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks. * Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor. After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation.

Disinfectant Use Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Students enrolled at Sun Yat-sen University Shenzhen Campus
• Willing to voluntarily participate, able to complete questionnaire surveys, exposure measurements, health scale assessments, and biological sample collection (including blood and urine)

You may not qualify if:

• Smoking
• Physically weak, unable to fully participate in the study

Sponsors & Collaborators

• National Natural Science Foundation of China: lead

Study Sites (1)

Sun Yat-sen University

Shenzhen, China

RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Jianbang Xiang

CONTACT

086+18810915464; xiangjb@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-10

Locations

CN (1)