Today is 2020-10-31

The relationship between Vitamin D andnovel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000031163 

最近更新日期:

Date of Last Refreshed on:

2020-03-23 

注册时间:

Date of Registration:

2020-03-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

维生素D与新型冠状病毒肺炎(COVID-19)的相关研究 

Public title:

The relationship between Vitamin D andnovel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

维生素D缺乏与新型冠状病毒肺炎(COVID-19)疾病严重程度的关联研究 

Scientific title:

The correlation between Vitamin D deficient and severe status of novel coronavirus pneumonia (COVID-19) patients 

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:

廖鑫 

研究负责人:

叶琨 

Applicant:

Xin Liao 

Study leader:

Kun Ye 

申请注册联系人电话:

Applicant telephone:

+86 15177947574 

研究负责人电话:

Study leader's telephone:

+86 18978817899 

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:

66552471@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yezi5729@163.com 

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:

广西南宁市青秀区桃源路6号 

研究负责人通讯地址:

广西南宁市青秀区桃源路6号 

Applicant address:

6 Taoyuan Road, Qingxiu District, Nanning, Guangxi Zhuang Autonomous Region, China 

Study leader's address:

6 Taoyuan Road, Qingxiu District, Nanning, Guangxi Zhuang Autonomous Region, 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:

广西壮族自治区人民医院 

Applicant's institution:

The People's Hospital of GuangXi Zhuang Autonomous Region 

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:

KY-LW-2020-2号 

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:

广西壮族自治区人民医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee of People’s Hospital of Guangxi Zhuang Autonomous Region 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-10 

伦理委员会联系人:

易中秋 

Contact Name of the ethic committee:

ZhongQiu Yi 

伦理委员会联系地址:

广西南宁市桃源路6号 

Contact Address of the ethic committee:

6 Taoyuan Road, Nanning, Guangxi Zhuang Autonomous Region, 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:

广西壮族自治区人民医院 

Primary sponsor:

The People's Hospital of GuangXi Zhuang Autonomous Region 

研究实施负责(组长)单位地址:

广西南宁市青秀区桃源路6号 

Primary sponsor's address:

6 Taoyuan Road, Qingxiu District, Nanning, Guangxi Zhuang Autonomous Region 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

南宁

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

Nanning

单位(医院):

广西壮族自治区人民医院

具体地址:

广西南宁市青秀区桃源路6号

Institution
hospital:

The People's Hospital of GuangXi Zhuang Autonomous Region

Address:

6 Taoyuan Road, Qingxiu District

经费或物资来源:

单位自筹 

Source(s) of funding:

Self-raised 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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 

研究目的:

探讨维生素D水平与新冠肺炎的病情进展、治疗效果、预后的相关性 

Objectives of Study:

To evluate the relationship between vitamin D deficinet and progression, treatment outcome and prognosis of COVID-19  

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:

参照国家卫生健康委颁布的《新型冠状病毒肺炎诊疗方案(试行第六版)》,确诊的新型冠状病毒肺炎患者 

Inclusion criteria

Patinets diagnosed with COVID-19 according to Diagnosis and treatment of novel coronavirus pneumonia (trial version sixth) 

排除标准:

未检测25(OH)D的样本 

Exclusion criteria:

25(OH)D level not available 

研究实施时间:

Study execute time:

From2020-02-16To 2022-02-16 

征募观察对象时间:

Recruiting time:

From2020-02-16To 2020-06-16 

干预措施:

Interventions:

组别:

Case series

样本量:

80

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):

广西壮族自治区 

市(区县):

南宁市 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region  

City:

NanNing City 

单位(医院):

广西壮族自治区人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

The People's Hospital of Guangxi Zhuang Autonomous Region  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

25羟基维生素d

指标类型:

主要指标 

Outcome:

25(OH)D

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

次要指标 

Outcome:

creatinine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白蛋白

指标类型:

次要指标 

Outcome:

albumin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

估计肾小球滤过率

指标类型:

次要指标 

Outcome:

Estimated glomerular filtration rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Hospital Day

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 0.1 years
最大 Max age 85 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):

连续纳入-无随机

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

N/A

盲法:

N/A

Blinding:

N/A

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):

通过发送信息至邮箱获取,邮箱地址:zhangguogx@hotmail.com

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

Obtained by sending email, Email:66552471@qq.com

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:

数据采集:CRF 数据管理:Excel

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

data collection:CRF data management:Excel

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-23
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