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生命早期n-3脂肪酸对后期生长发育和健康的影响及表观遗传机制研究
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注册号:

Registration number:

ChiCTR-OCH-14004900 

最近更新日期:

Date of Last Refreshed on:

2014-10-05 

注册时间:

Date of Registration:

2014-07-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

生命早期n-3脂肪酸对后期生长发育和健康的影响及表观遗传机制研究 

Public title:

The Effects of Early N-3 Polyunsaturated Fatty Acids on Later Health and the Underlying Epigenetic Mechanisms 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

生命早期n-3脂肪酸对后期生长发育和健康的影响及表观遗传机制研究 

Scientific title:

The Effects of Early N-3 Polyunsaturated Fatty Acids on Later Health and the Underlying Epigenetic M 

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:

樊超男 

研究负责人:

齐可民 

Applicant:

Fan Chaonan 

Study leader:

Qi Kemin 

申请注册联系人电话:

Applicant telephone:

+86 010-59616899 

研究负责人电话:

Study leader's telephone:

+86 010-59616891 

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:

fanchaonan-2005@163.com 

研究负责人电子邮件:

Study leader's E-mail:

qkm732@sohu.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:

北京市西城区南礼士路56号 

研究负责人通讯地址:

北京市西城区南礼士路56号 

Applicant address:

No.56 Nan-li-shi Road, Beijing, China 

Study leader's address:

No.56 Nan-li-shi Road, Beijing, 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:

首都医科大学附属北京儿童医院 

Applicant's institution:

Beijing Children's Hospital, Capital Medical Unive 

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:

2014-46 

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:

首都医科大学附属北京儿童医院儿科研究所医学伦理委员会 

Name of the ethic committee:

Institutional Committee in Beijing Children's Hospital of Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-02-18 

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:

首都医科大学附属北京儿童医院 

Primary sponsor:

Beijing Children's Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区南礼士路56号 

Primary sponsor's address:

No.56 Nan-li-shi Road, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京儿童医院

具体地址:

北京市西城区南礼士路56号

Institution
hospital:

Beijing Children's Hospital, Capital Medical Unive

Address:

No.56 Nan-li-shi Road, Beijing, China

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:

肥胖、代谢综合征、过敏性疾病、注意力缺陷多动等 

Target disease:

obesity, metabolic syndrome, allergic diseases, attention deficient and hyperactivity disease (ADHD) 

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:

其它 

Study phase:

N/A 

研究目的:

通过对母婴体内及母乳中n-3多不饱和脂肪酸(PUFAs)含量及遗传因素(脂肪酸去饱和酶基因多态性)分析的基础上,探讨n-3 PUFAs营养状态(低、中、高含量)与学龄前及学龄期生长发育(体格、心理行为、肠道菌群等)、疾病发生(肥胖、代谢综合征、过敏性疾病、注意力缺陷多动等)之间的关系,进而从DNA甲基化等表观遗传途径研究其影响健康的机制。不仅有助于揭示n-3 PUFAs影响健康的新机制,还有助于制定母婴膳食n-3 PUFAs的参考摄入量,对于实现儿童更好的即时生长发育以及成年期的健康至关重要。 

Objectives of Study:

In this project, we plan to use pregnant and breeding mothers and their infants as subjects, to investigate the relationship between body n-3 PUFA status (low, medium and high levels in the first 1,000 days of life and in later growth and development (physical and mental, and gut microbiota) and diseases such as obesity, metabolic syndrome, allergic diseases, attention deficient and hyperactivity disease (ADHD), etc. by prospective cohort study, and furthermore the related epigenetic markers. Meanwhile, analysis in the role of genetic variants of FADS in body n-3 PUFA synthesis and content will also be conducted. This study will be helpful in understanding the n-3 PUFA status in diet and human body in Chinese breeding women and children, and directing establishment of RNI for n-3 PUFAs. Furthermore, the findings will permit an early intervention for the modification of eating styles and the selection of culturally proper foods, and these will have long-term effects on reduction on the future incidence of n-3 PUFA deficiency related diseases in later ages. 

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:

年龄在22~35 岁之间处于孕晚期的初产妇 

Inclusion criteria

Primipara aged between 20 and 30 in the third trimester 

排除标准:

患心脏病、糖尿病及其它明确的代谢性疾病、感染性疾病,孕期曾服用或正在服用n-3 PUFAs 补充剂。 

Exclusion criteria:

Suffered from heart disease, diabetes, or other specific metabolic diseases, infectious diseases, and supplemented with n-3 PUFAs in pregnancy 

研究实施时间:

Study execute time:

From2015-01-01To  

征募观察对象时间:

Recruiting time:

From2015-01-01To  

干预措施:

Interventions:

组别:

三组

样本量:

10500

Group:

three

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):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京儿童医院 

单位级别:

三级甲等医院 

Institution
hospital:

Capital Medical University, Beijing Children's Hos  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

n-3多不饱和脂肪酸

指标类型:

主要指标 

Outcome:

N-3 Polyunsturated Fatty ACID

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体格发育

指标类型:

次要指标 

Outcome:

physical

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理指标

指标类型:

次要指标 

Outcome:

mental

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群

指标类型:

次要指标 

Outcome:

gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DNA甲基化

指标类型:

次要指标 

Outcome:

DNA methylatio

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:

母乳

组织:

Sample Name:

breast milk

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

末梢血

组织:

Sample Name:

peripheral blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

faeces

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

静脉血

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 0 years
最大 Max age 6 years

性别:

Gender:

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

Blinding:

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):

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

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:

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

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:

 2014-07-07
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