今天是:2022-07-06 星期三

我国重点人群铁需要和膳食评估应用研究
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-09000581 

最近更新日期:

Date of Last Refreshed on:

2015-05-16 

注册时间:

Date of Registration:

2009-10-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

我国重点人群铁需要和膳食评估应用研究 

Public title:

A study on iron requirement and dietary evaluation in susceptible Chinese populations 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

我国重点人群铁需要和膳食评估应用研究 

Scientific title:

A study on iron requirement and dietary evaluation in susceptible Chinese population 

研究课题代号(代码):

Study subject ID:

2008BAI58B02 

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:

黄振武 

研究负责人:

黄振武 

Applicant:

Zhenwu Huang 

Study leader:

Zhenwu Huang 

申请注册联系人电话:

Applicant telephone:

+86 010-83132906 

研究负责人电话:

Study leader's telephone:

+86 010-83132906 

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:

zhenwuhuang@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhenwuhuang@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:

北京市宣武区南纬路29号 

研究负责人通讯地址:

北京市宣武区南纬路29号 

Applicant address:

29 Nanwei Road, Xuanwu District, Beijing 

Study leader's address:

29 Nanwei Road, Xuanwu 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:

Naitional Institute for Nutrition and Food Security, 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:

Num2009-08 

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道德委员会 

Name of the ethic committee:

Ethic Committee of Naitional Institute for Nutrition and Food Security, Chinese Center for Disease C 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-03-18 

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:

复旦大学附属华东医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

上海市延安西路221号 

Primary sponsor's address:

221 Yan-an West Rd., Shanghai 

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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家科技部

具体地址:

北京市海淀区双清路83号

Institution
hospital:

Ministry of Science and Technology of the People′s Republic of China

Address:

No. 83, Shuangqing Road, Haidian District, Beijing

经费或物资来源:

科技部 

Source(s) of funding:

Ministry of Science and Technology of China 

研究疾病:

缺铁性贫血 

Target disease:

IDA/iron deficiency 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

获得不同中国人群铁的生理需要量;提出新的中国不同人群膳食铁需要量。 

Objectives of Study:

To identify dietary iron requirement in three Chinese population of children, adult and the elderly. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

贫血判断标准: 年龄 血红蛋白值(g/L) 6-59月龄 <110 5-11岁 <115 12-14岁 <120 非孕女子(>15岁) <120 男子(>15岁) <130 

Inclusion criteria

Subjects aged 6 to 75 years old with IDA/iron deficiency 

排除标准:

严重消化系统疾病、代谢性疾病和其他原因引起的贫血,近期营养剂补充 

Exclusion criteria:

1. Diseases (except for IDA) or conditions known to affect iron absorption and metabolism. 2. Patients taken nutrients or medicines recently. 

研究实施时间:

Study execute time:

From2008-12-23To 2010-12-23 

征募观察对象时间:

Recruiting time:

From2009-10-01To 2009-12-23 

干预措施:

Interventions:

组别:

铁营养包组

样本量:

228

Group:

Iron group

Sample size:

干预措施:

(老人/成人/儿童) 每组76人,南北各半、男女各半

干预措施代码:

Intervention:

(old man/adult/children) each group of 76 people, half the north and south, evenly divided between male and female

Intervention code:

组别:

安慰剂组

样本量:

228

Group:

Placebo group

Sample size:

干预措施:

(老人/成人/儿童) 每组76人,南北各半、男女各半

干预措施代码:

Intervention:

(old man/adult/children) each group of 76 people, half the north and south, evenly divided between male and female

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华东医院 

单位级别:

三甲医院 

Institution
hospital:

Huadong Hospital Attached Fudan University; Baiqiueng Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

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:

省部级 

Institution
hospital:

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

Level of the institution:

Provincial or ministry level 

测量指标:

Outcomes:

指标中文名:

Indices for iron deficiency

指标类型:

主要指标 

Outcome:

Indices for iron deficiency

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膳食铁摄取及其影响因子

指标类型:

主要指标 

Outcome:

Fraction of bioavailability of iron

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膳食铁吸收和利用

指标类型:

附加指标 

Outcome:

Iron, vitamin C and folic acid intake level in daily dietary

Type:

Additional 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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 6 years
最大 Max age 75 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):

randomization table

盲法:

观察对象;科研人员 是 干预措施只有生产厂家知道

Blinding:

Subjects: Blinding Trialists: Blinding Trial designer: Blinding Trial designer: Blinding Statisticia

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

中国疾病预防控制中心营养与食品安全所及合作单位

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

National Institute for Nutrition and Food Security, Chinese Center for Disease Control and Preventio

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:

中国疾病预防控制中心营养与食品安全所及合作单位

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

National Institute for Nutrition and Food Security, Chinese Center for Disease Control and Preventio

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-10-30
返回列表