Acute Health Effects of Ozone Exposure
赞助:
Fudan University
合作者:
信息的提供 (责任方):
Haidong Kan，Fudan University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 30, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | December 3, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Changes of FEV1[ Time Frame: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning ] Changes of forced expiratory volume in 1 second Changes of FVC[ Time Frame: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning ] Changes of forced vital capacity |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Acute Health Effects of Ozone Exposure | ||
| 正式标题 ICMJE | Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study | ||
| 简要概况 | This is a randomized controlled human exposure crossover study. We aim to investigate the acute health effects of ozone exposure in healthy young adults. |
||
| 详细说明 | The investigators will conduct a randomized controlled human exposure crossover study among 32 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to clean air and once to 200 ppb ozone in a chamber for 2 hours. During the 2-hour exposure, each subject will be requested to alternate 15 minutes of rest and 15 minutes of exercise on a treadmill. The exercise workload will be adjusted to achieve the targeted ventilation of 20±1 L/min/m2 body surface area. Ozone will be generated by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced into the chamber. The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 50%±5%, respectively. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Basic Science |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
32 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | December 3, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Living in Shanghai during study period; - Ability to complete the exercise to achieve the ventilation of 20±1 L/min/m2 body surface area; - Body mass index >18.5 and ≤30 (30 is the lower limit for class 2 obesity for Chinese). Exclusion Criteria: - Smoking and alcohol abuse; - Current drug and dietary supplements intake; - Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; - Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; - Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; - Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; - Subjects who have a history of major surgery; - Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65); - Abnormal baseline 12-lead resting electrocardiogram; - Abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (GPT). | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：30 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | Haidong Kan，Fudan University | ||
| 研究赞助商 ICMJE | Fudan University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | Fudan University | ||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号