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孕妇和青少年铁生理需要量研究
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注册号:

Registration number:

ChiCTR-OCH-14004302 

最近更新日期:

Date of Last Refreshed on:

2018-09-11 

注册时间:

Date of Registration:

2014-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

孕妇和青少年铁生理需要量研究 

Public title:

Study on iron physiological requirements in pregnant women and children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

孕妇和青少年铁生理需要量研究 

Scientific title:

Study on iron physiological requirements in pregnant women and children 

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:

张宇 

研究负责人:

杨晓光 

Applicant:

Zhang Yu 

Study leader:

Yang Xiaoguang 

申请注册联系人电话:

Applicant telephone:

+86 10 83132808 

研究负责人电话:

Study leader's telephone:

+86 10 83132798 

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:

hmuyufang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xgyangcdc@vip.sina.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:

北京市西城区南纬路29号 

研究负责人通讯地址:

北京市西城区南纬路29号 

Applicant address:

29 Nanwei Road, Xicheng district, Beijing 

Study leader's address:

29 Nanwei Road, Xicheng district, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100050 

研究负责人邮政编码:

Study leader's postcode:

100050 

申请人所在单位:

中国疾病预防控制中心营养与食品安全所 

Applicant's institution:

National Institute for Nutrition and Food Safety, Chinese Center for Disease Control and Prevention 

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:

2013-011 

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:

中国疾病预防控制中心营养与食品安全所伦理审查委员会 

Name of the ethic committee:

Ethics committee of national institute for nutrition and food safety, chinese center for disease control and prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-03-12 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国疾病预防控制中心营养与食品安全所 

Primary sponsor:

National institute for nutrition and food safety, Chinese Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

北京市西城区南纬路29号 

Primary sponsor's address:

29 Nanwei Road, Xicheng district, Beijing 

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):

中国疾病预防控制中心营养与食品安全所

具体地址:

北京市西城区南纬路29号

Institution
hospital:

National institute for nutrition and food safety, chinese center for disease control and prevention

Address:

29 Nanwei Road, Xicheng district, Beijing

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

铁生理需要量 

Target disease:

Iron physiological requirements 

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:

I期临床试验 

Study phase:

研究目的:

获取孕妇和儿童铁生理需要量 

Objectives of Study:

To get the iron physiological requirements of pregnant women and children 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.铁营养状况正常; 2.近期无药物、射线和营养补充剂的接触史; 3.签署知情同意书 

Inclusion criteria

1. Normal iron status; 2. No recent history of exposure to drugs, radiation and nutritional supplements; 3. Signed informed consent. 

排除标准:

1.缺铁性贫血及其他代谢性疾病者; 2.无法配合随访和样品收集. 

Exclusion criteria:

1. Iron deficiency anemia and other metabolic diseases; 2. Not complete follow-up and sample collection. 

研究实施时间:

Study execute time:

From2015-05-01To 2017-05-01 

干预措施:

Interventions:

组别:

未怀孕的育龄妇女

样本量:

61

Group:

non-pregnant women of childbearing age

Sample size:

干预措施:

铁同位素干预

干预措施代码:

Intervention:

Iron isotope intervention

Intervention code:

组别:

婴幼儿

样本量:

20

Group:

Infants

Sample size:

干预措施:

采血

干预措施代码:

Intervention:

Collect blood samples

Intervention code:

组别:

儿童

样本量:

70

Group:

Child

Sample size:

干预措施:

铁同位素干预

干预措施代码:

Intervention:

Iron isotope intervention

Intervention code:

组别:

孕妇

样本量:

24

Group:

Pregnancy women

Sample size:

干预措施:

铁同位素干预

干预措施代码:

Intervention:

Iron isotope intervention

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):

中国疾病预防控制中心营养与食品安全所 

单位级别:

科研单位 

Institution
hospital:

National institute for nutrition and food safety, chinese center for disease control and prevention  

Level of the institution:

Research units 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北医科大学 

单位级别:

大学 

Institution
hospital:

Hebei Medical University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

铁同位素丰度值

指标类型:

主要指标 

Outcome:

Iron isotope abundances

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、粪便中铁含量

指标类型:

主要指标 

Outcome:

iron content of blood and fece

Type:

Primary 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:

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:

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 35 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):

随机数字表

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

Random number table

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-02-14
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