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临床试验/NCT06637826
NCT06637826进行中(未招募)1 期

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

National Natural Science Foundation of China1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
64
试验地点
1
主要终点
64 Participants with Disinfectant Products-Related Adverse Events

研究概览

简要总结

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. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

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

研究组 & 干预措施

Blank Control Group

No Intervention

Disinfectant Use Control Group

Experimental

干预措施: Quaternary Ammonium Compound Disinfectants (Behavioral)

Disinfectant Use Control Group

Experimental

干预措施: Alcohol-based Disinfectants (Behavioral)

结局指标

主要结局

64 Participants with Disinfectant Products-Related Adverse Events

时间窗: From enrollment to the end of treatment at 3 months

次要结局

未报告次要终点

研究者

发起方
National Natural Science Foundation of China
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Xiang Jianbang

Professor

National Natural Science Foundation of China

研究点 (1)

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