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Impact of vitamin D deficiency on prognosis of patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029732 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

维生素D缺乏对新型冠状病毒 (COVID-19) 肺炎患者预后的影响 

Public title:

Impact of vitamin D deficiency on prognosis of patients with novel 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缺乏对新型冠状病毒肺炎患者预后的影响 

Scientific title:

Impact of vitamin D deficiency on prognosis of patients novel coronavirus pneumonia (COVID-19) 

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:

郭军 

研究负责人:

郭军 

Applicant:

Jun Guo 

Study leader:

Jun Guo 

申请注册联系人电话:

Applicant telephone:

+86 15388178461 

研究负责人电话:

Study leader's telephone:

+86 15388178461 

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:

guojun@wchscu.cn 

研究负责人电子邮件:

Study leader's E-mail:

guojun@wchscu.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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2020年 审(128)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee, West China Hospital of Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

韩玉榕、赵芸芸 

Contact Name of the ethic committee:

Yurong Han, Yunyun Zhao 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院老八教412-413室 

Contact Address of the ethic committee:

Room 412-413, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University  

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

四川省科技厅 

Source(s) of funding:

Science and Technology Department of Sichuan Province 

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:

探索性研究/预试验 

Study phase:

研究目的:

探讨新型冠状病毒肺炎患者血清维生素D水平与患者预后的关系。 

Objectives of Study:

Relationship between serum vitamin D levels and clinical prognosis in patients with novel coronavirus pneumonia. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1、年龄 ≥ 18 岁; 2、符合新型冠状病毒 (2019-nCov) 感染的肺炎疑似病例诊断标准的人群。 

Inclusion criteria

1. Aged >= 18 years. 2. Patients who meet the diagnostic criteria of suspected cases of pneumonia caused by novel coronavirus infection.  

排除标准:

1. 无任何临床和胸部影像学表现的患者; 2. 入院前一周内有补充维生素D或钙。 3. 严重衰竭患者,存在慢性脏器功能不全; 4. 恶性肿瘤;免疫系统疾病;接受放化疗等。 5. 妊娠:育龄女性妊娠试验阳性;哺乳期妇女未停止哺乳。  

Exclusion criteria:

1. Patients without any clinical and chest imaging findings; 2. Supplementation with vitamin D or calcium within one week before admission 3. Patients with severe failure with chronic organ dysfunction; 4. Malignant tumors; diseases of the immune system; radiation and chemotherapy. 5. Pregnancy: The pregnancy test is positive for women of childbearing age; the breastfeeding women have not stopped breastfeeding. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-04-10 

干预措施:

Interventions:

组别:

维生素D缺乏组

样本量:

104

Group:

Vitamin D deficiency group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

维生素D正常组

样本量:

52

Group:

Vitamin D normal group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

川北医学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三甲 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

芜湖市第二人民医院 

单位级别:

三甲 

Institution
hospital:

2nd hospital of Wuhu City  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

绵阳市中心医院 

单位级别:

三甲 

Institution
hospital:

Central Hospital of Mianyang  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

ROX指数

指标类型:

主要指标 

Outcome:

ROX index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

length of stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

危重化率

指标类型:

次要指标 

Outcome:

the rate of transfer to critical ill patients

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU住院日

指标类型:

次要指标 

Outcome:

length of stay in ICU

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天死亡率

指标类型:

次要指标 

Outcome:

28-day mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

次要指标 

Outcome:

complication

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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

Nil

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):

不公开

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

Private

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:

电子采集和管理系统

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

Electronic collection and management system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-10
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