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: |
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English Acronym: |
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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: |
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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): |
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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 |
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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 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
Ethic Committee of Naitional Institute for Nutrition and Food Security, Chinese Center for Disease C |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
National Institute for Nutrition and Food Security, Chinese Center for Disease Control and Prevention |
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研究实施负责(组长)单位地址: |
上海市延安西路221号 |
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Primary sponsor's address: |
221 Yan-an West Rd., Shanghai |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
科技部 |
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Source(s) of funding: |
Ministry of Science and Technology of China |
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研究疾病: |
缺铁性贫血 |
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Target disease: |
IDA/iron deficiency |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
Study phase: |
1 |
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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。 |
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Objectives of Study: |
To identify dietary iron requirement in three Chinese population of children, adult and the elderly. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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 |
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Inclusion criteria |
Subjects aged 6 to 75 years old with IDA/iron deficiency |
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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 |
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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: |
从From2008-12-23至To 2010-12-23 |
征募观察对象时间: Recruiting time: |
从From2009-10-01至To 2009-12-23 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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): |
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Calculated Results after
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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 |