Today is 2019-12-08

Investigation for drinking and urination behavior and internal microplastics of sports people in college
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注册号:

Registration number:

ChiCTR1900025710 

最近更新日期:

Date of Last Refreshed on:

2019-09-06 

注册时间:

Date of Registration:

2019-09-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

大学运动人群饮水排尿行为与体内微塑料情况调查 

Public title:

Investigation for drinking and urination behavior and internal microplastics of sports people in college 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

大学运动人群饮水排尿行为与体内微塑料情况调查 

Scientific title:

Investigation for drinking and urination behavior and internal microplastics of sports people in college 

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:

李亦斌 

研究负责人:

马冠生 

Applicant:

Li Yibin 

Study leader:

Ma Guansheng 

申请注册联系人电话:

Applicant telephone:

+86 15600561995 

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:

1310306130@bjmu.edu.cn 

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号北京大学医学部 

研究负责人通讯地址:

北京市海淀区学院路38号北京大学医学部 

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:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

北京大学公共卫生学院 

Applicant's institution:

School of Public Health, Health Science Center, Peking University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

IRB00001052-19051 

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:

Peking University biomedical ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

宋艳双 

Contact Name of the ethic committee:

Song Yanshuang 

伦理委员会联系地址:

北京市海淀区学院路38号北京大学医学部 

Contact Address of the ethic committee:

Peking University Health Science Center, 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:

北京大学公共卫生学院 

Primary sponsor:

School of Public Health, Health Science Center, Peking University 

研究实施负责(组长)单位地址:

北京市海淀区学院路38号北京大学医学部 

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):

北京大学公共卫生学院

具体地址:

北京市海淀区学院路38号北京大学医学部

Institution
hospital:

School of public health, Peking University

Address:

38 Xueyuan Road, Haidian District, Beijing, China

经费或物资来源:

北京大学教育基金会 

Source(s) of funding:

Peking University education foundation 

研究疾病:

饮水排尿行为,体内微塑料 

Target disease:

drinking and urination behavior and internal microplastics 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

(1)收集调查对象的饮水量和饮水行为、尿液量和排尿行为等数据。 (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,为对运动人群开展针对性的饮水教育提供资料。 

Objectives of Study:

(1) To collect the data such as water consumption and drinking water behavior, urine volume and urination behavior of the respondents, etc. (2) To analyze the relationship between the daily water consumption and urine volume, urine osmotic pressure and other indicators of the respondents, so as to provide data for targeted water drinking education for sports people. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

年龄在18~25岁之间。 

Inclusion criteria

Aged between 18 and 25 years old. 

排除标准:

排除标准:患口腔、内分泌疾病、肾脏疾病、胃肠道疾病、代谢性疾病和其他慢性病或认知功能障碍者,一个月内服用过药物或维生素等其他保健品,以及有吸烟习惯者。 

Exclusion criteria:

Students with oral, endocrine, kidney, gastrointestinal, metabolic and other chronic diseases or cognitive disorders, who have taken drugs or other health care products such as vitamins within one month, and who have the habit of smoking. 

研究实施时间:

Study execute time:

From2019-05-08To 2019-06-22 

干预措施:

Interventions:

组别:

无干预分组

样本量:

112

Group:

Case series

Sample size:

干预措施:

无干预措施

干预措施代码:

Intervention:

none

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):

北京体育大学 

单位级别:

大学 

Institution
hospital:

Beijing Sport University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

饮水量

指标类型:

主要指标 

Outcome:

water consumption

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:

urine 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:

粪便微塑料

指标类型:

主要指标 

Outcome:

Microplastics in faeces

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:

血浆渗透压

指标类型:

主要指标 

Outcome:

Plasma 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:

运动强度

指标类型:

主要指标 

Outcome:

exercise intensity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

次要指标 

Outcome:

height

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

weight

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰围

指标类型:

次要指标 

Outcome:

waist

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体成分

指标类型:

次要指标 

Outcome:

body composition

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆离子浓度

指标类型:

次要指标 

Outcome:

Plasma ion concentration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液离子浓度

指标类型:

次要指标 

Outcome:

Urine ion concentration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

食物水摄入量

指标类型:

次要指标 

Outcome:

water consumption in food

Type:

Secondary 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:

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:

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:

粪便

组织:

Sample Name:

faeces

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

无随机分组

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

数据录入完成后,会在临床试验公共管理平台(ResMan)进行公布

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

After the data type-in completed, it will be published on the public clinical trial management platform (ResMan)

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:

CRF数据采用纸质表格进行采集,由受试者或实验者进行填写,填写后专门分类进行保存,之后通过Epidata双录入转化为EDC数据。EDC数据通过临床试验公共管理平台进行公开。

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

CRF data were collected using paper and written by subjects or experimenters and were classified and saved. Afterwards, Epidata double input was used to convert the data into EDC data. EDC data are made available through the public management platform for clinical trials.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-06
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