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Paradigm Shifts in Vitamin D Testing and Diagnosis: A Decade-long Observational Study of Nearly One million Tests
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注册号:

Registration number:

ChiCTR2100052300 

最近更新日期:

Date of Last Refreshed on:

2021-10-24 

注册时间:

Date of Registration:

2021-10-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Please submit the approval letter of ethics review Paradigm Shifts in Vitamin D Testing and Diagnosis: A Decade-long Observational Study of Nearly One million Tests 

Public title:

Paradigm Shifts in Vitamin D Testing and Diagnosis: A Decade-long Observational Study of Nearly One million Tests 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Paradigm Shifts in Vitamin D Testing and Diagnosis: A Decade-long Observational Study of Nearly One million Tests 

Scientific title:

Paradigm Shifts in Vitamin D Testing and Diagnosis: A Decade-long Observational Study of Nearly One million Tests 

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:

Muhammad Abbas Abid 

研究负责人:

Hafsa Majid 

Applicant:

Muhammad Abbas Abid 

Study leader:

Hafsa Majid 

申请注册联系人电话:

Applicant telephone:

+92 02134861927 

研究负责人电话:

Study leader's telephone:

+92 02134861927 

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:

mabbas.abid@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

hafsa.majid@aku.edu 

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:

2nd Parklands Avenue & Limuru Road, Nairobi, Kenya, Pakistan 

研究负责人通讯地址:

2nd Parklands Avenue & Limuru Road, Nairobi, Kenya, Pakistan 

Applicant address:

2nd Parklands Avenue & Limuru Road, Nairobi, Kenya, Pakistan 

Study leader's address:

2nd Parklands Avenue & Limuru Road, Nairobi, Kenya, Pakistan 

申请注册联系人邮政编码:

Applicant postcode:

30270 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

巴基斯坦Aga Khan University 

Applicant's institution:

Aga Khan University, Pakistan 

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:

3930-Pat-ERC- 15 

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:

Aga Khan University Ethics Review Committee  

Name of the ethic committee:

Aga Khan University Ethics Review Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

Aga Khan University Ethics Review Committee  

Contact Name of the ethic committee:

Aga Khan University Ethics Review Committee  

伦理委员会联系地址:

Aga Khan University Stadium Road, Karachi, Pakistan 

Contact Address of the ethic committee:

Aga Khan University Stadium Road, Karachi, Pakistan 

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:

None 

Primary sponsor:

None 

研究实施负责(组长)单位地址:

N/A 

Primary sponsor's address:

Not Applicable 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

None 

Source(s) of funding:

None 

研究疾病:

Vitamin D deficiency 

Target disease:

Vitamin D deficiency 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

Determine patterns of vitamin D testing and vitamin D levels in Pakistani population over a period of 10 years. 

Objectives of Study:

Determine patterns of vitamin D testing and vitamin D levels in Pakistani population over a period of 10 years. 

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:

All patients presenting for vitamin D test. 

Inclusion criteria

All patients presenting for vitamin D test. 

排除标准:

Incomplete test results. 

Exclusion criteria:

Incomplete test results. 

研究实施时间:

Study execute time:

From2010-01-01To 2021-05-31 

征募观察对象时间:

Recruiting time:

From2010-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

903282

Group:

Case series

Sample size:

干预措施:

None

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

巴基斯坦 

省(直辖市):

信德 

市(区县):

 

Country:

Pakistan 

Province:

Sindh 

City:

 

单位(医院):

Aga Khan University 

单位级别:

三级医院 

Institution
hospital:

Aga Khan University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

Rate of Hypovitaminosis

指标类型:

主要指标 

Outcome:

Rate of Hypovitaminosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Rate of hypervitaminosis

指标类型:

次要指标 

Outcome:

Rate Hypervitaminosis

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:

No

组织:

Sample Name:

None

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 years
最大 Max age 80 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):

No

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

Retrospective data. Randomization not required.

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

No

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):

No

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

N/A

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:

Integrated Laboratory Management System

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

Integrated Laboratory Management System

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-24
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