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The associate of polymorphisms of vitamin D metabolism-related genes with autism, and the treatment of autism with vitamin D
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注册号:

Registration number:

ChiCTR-CCC-13004498 

最近更新日期:

Date of Last Refreshed on:

2016-08-29 

注册时间:

Date of Registration:

2013-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

维生素D代谢相关基因的单核苷酸多态性与孤独症易感性的关联及维生素D治疗孤独症疗效观察 

Public title:

The associate of polymorphisms of vitamin D metabolism-related genes with autism, and the treatment of autism with vitamin D 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

维生素D代谢相关基因的单核苷酸多态性与孤独症易感性的关联及维生素D治疗孤独症疗效观察 

Scientific title:

The associate of polymorphisms of vitamin D metabolism-related genes with autism, and the treatment of autism with vitamin D 

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:

李宁 

研究负责人:

贾飞勇 

Applicant:

Ning Li 

Study leader:

Feiyong Jia 

申请注册联系人电话:

Applicant telephone:

+86 13596083041 

研究负责人电话:

Study leader's telephone:

+86 13943003914 

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:

lining19860401@126.com 

研究负责人电子邮件:

Study leader's E-mail:

erkekangfujia@163.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:

解放大路4058号,吉林大学第一医院康复中心 

研究负责人通讯地址:

解放大路4058号,吉林大学第一医院康复中心 

Applicant address:

4058 Jiefang Road, Changcun, Jilin, China 

Study leader's address:

4058 Jiefang Road, Changcun, Jilin, China 

申请注册联系人邮政编码:

Applicant postcode:

130000 

研究负责人邮政编码:

Study leader's postcode:

130000 

申请人所在单位:

吉林大学白求恩第一医院 

Applicant's institution:

First Hospital of Jilin University 

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:

2013-192 

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:

吉林大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of First Hospital of Jilin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-10 

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:

吉林大学白求恩第一医院 

Primary sponsor:

Bethune First Hospital of Jilin University 

研究实施负责(组长)单位地址:

长春市新民大街71号 

Primary sponsor's address:

71 Xinmin Street, Changchun, Jilin, 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):

吉林省

市(区县):

长春

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

吉林大学白求恩第一医院

具体地址:

长春市新民大街71号

Institution
hospital:

Bethune First Hospital of Jilin University

Address:

71 Xinmin Street, Changchun, Jilin, China

经费或物资来源:

吉林大学第一医院 

Source(s) of funding:

First Hospital of Jilin University 

研究疾病:

孤独症 

Target disease:

autism 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探索维生素D代谢关键酶及维生素结合蛋白基因的单核苷酸多态性与孤独症易感性的关系 

Objectives of Study:

To explore the key metabolic enzymes and vitamin D binding protein gene of single nucleotide polymorphisms and susceptibility to autism 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

根据DSM-IV孤独症诊断标准、ADIR及ADOS孤独症诊断量表检查确诊为孤独症或孤独症谱系障碍者 

Inclusion criteria

According to the DSM-IV, Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedul-e (ADOS)children have been diagnosed as autism or Autism Spectrum Disorder. 

排除标准:

合并其他代谢性疾病 

Exclusion criteria:

with other metabolic disorders 

研究实施时间:

Study execute time:

From2013-10-09To  

干预措施:

Interventions:

组别:

孤独症组

样本量:

60

Group:

autism

Sample size:

干预措施:

补充25羟维生素D

干预措施代码:

Intervention:

Supliment of vitamin D

Intervention code:

组别:

对照组

样本量:

60

Group:

control

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学白求恩第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

Bethune First Hospital of Jilin University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

孤独症组SNP等位基因频率

指标类型:

主要指标 

Outcome:

Gene frequency

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对照组SNP等位基因频率

指标类型:

主要指标 

Outcome:

Gene frequency

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆25羟维生素D水平

指标类型:

次要指标 

Outcome:

25 (OH) D

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:

Gene frequency

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:

血浆

组织:

Sample Name:

Plasma

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 1 years
最大 Max age 11 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):

NA

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

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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:

 2013-11-30
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