饮水及排尿行为调查

注册号:

Registration number:

ChiCTR2100045268 

最近更新日期:

Date of Last Refreshed on:

2021-11-16 02:09:17 

注册时间:

Date of Registration:

2021-04-10 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

饮水及排尿行为调查

Public title:

Investigation on drinking water and urination behavior

注册题目简写:

English Acronym:

研究课题的正式科学名称:

青年大学生四季饮水及排尿行为调查

Scientific title:

Investigation on drinking water and urination behavior of young college students in four seasons

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

芦俊博 

研究负责人:

马冠生 

Applicant:

Lu Junbo 

Study leader:

Ma Guansheng 

申请注册联系人电话:

Applicant telephone:

+86 18845145448

研究负责人电话:

Study leader's
telephone:

+86 13801080336

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

ljb_breeze66@163.com

研究负责人电子邮件:

Study leader's E-mail:

mags@bjmu.edu.cn

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

北京市海淀区学院路38号

研究负责人通讯地址:

北京市海淀区学院路38号

Applicant address:

38 Xueyuan Road, Haidian District, Beijing, China

Study leader's address:

38 Xueyuan Road, Haidian District, Beijing, China

申请注册联系人邮政编码:

Applicant postcode:

100083

研究负责人邮政编码:

Study leader's postcode:

100083

申请人所在单位:

北京大学医学部

Applicant's institution:

Peking University Health Science Center

研究负责人所在单位:

北京大学医学部

Affiliation of the Leader:

Peking University Health Science Center

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

IRB00001052-21013

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

北京大学生物医学伦理委员会

Name of the ethic committee:

Ethics Committee of Peking University Biomedical

伦理委员会批准日期:

Date of approved by ethic committee:

2021-03-21 00:00:00

伦理委员会联系人:

赵励彦

Contact Name of the ethic committee:

Zhao Liyan

伦理委员会联系地址:

北京市海淀区学院路38号

Contact Address of the ethic committee:

38 Xueyuan Road, Haidian District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

北京大学医学部

Primary sponsor:

Peking University Health Science Center

研究实施负责(组长)单位地址:

北京市海淀区学院路38号

Primary sponsor's address:

38 Xueyuan Road, Haidian District, Beijing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学医学部

具体地址:

海淀区学院路38号

Institution
hospital:

Peking University Health Science Center

Address:

38 Xueyuan Road, Haidian District

国家:

中国

省(直辖市):

河北

市(区县):

保定

Country:

China

Province:

Hebei

City:

Baoding

单位(医院):

河北大学医学部

具体地址:

莲池区裕华东路342号

Institution
hospital:

Hebei University Health Science Cente

Address:

342 Yuhua Road East, Lianchi District

经费或物资来源:

自筹经费

Source(s) of funding:

self-funded

研究疾病:

饮水、排尿  

Target disease:

Drinking water,Urination

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

1.收集受试者的饮水和饮水行为、尿量和排尿行为数据; 2.分析调查对象每日饮水量与尿液量及尿液渗透压等指标之间的关系,为对青年大学生开展针对性的饮水教育提供资料。  

Objectives of Study:

1.Data of water consumption and drinking behavior, urine volume and urination behavior of the subjects were collected; 2.To analyze the relationship between daily drinking water volume, urine volume, urine osmotic pressure and other indicators of the respondents, so as to provide information for carrying out targeted drinking water education for young college students.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

有吸烟习惯者。

Exclusion criteria:

Having the habit of smoking.

研究实施时间:

Study execute time:

From 2021-04-18 00:00:00 To 2022-09-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2021-04-09 00:00:00 To 2021-04-17 00:00:00

干预措施:

Interventions:

组别:

连续入组

样本量:

161

Group:

case series

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学医学部 

单位级别:

大学 

Institution
hospital:

Peking University Health Science Center

Level of the institution:

University

国家:

中国

省(直辖市):

河北 

市(区县):

保定 

Country:

China

Province:

Hebei

City:

Baoding

单位(医院):

河北大学医学部 

单位级别:

大学 

Institution
hospital:

Hebei University Health Science Center

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

尿钠

指标类型:

主要指标

Outcome:

Urine sodium

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿钾

指标类型:

主要指标

Outcome:

Urinary potassium

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液渗透压

指标类型:

主要指标

Outcome:

Urine osmotic pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿比重

指标类型:

主要指标

Outcome:

Urine specific gravity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液颜色

指标类型:

主要指标

Outcome:

Urine color

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血液渗透压

指标类型:

主要指标

Outcome:

Blood osmotic pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标

Outcome:

Blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

blood glucose

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

饮水量

指标类型:

主要指标

Outcome:

Drinking volume

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排尿量

指标类型:

主要指标

Outcome:

amount of urine

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 25 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

数据均保存至项目负责人处,可直接从项目负责人获取数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Data are saved to the project leader and can be obtained directly from the project leade

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据由项目负责人保存

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The data is saved by the project leader

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-04-10 00:54:18