Today is 2022-08-12

Effects of folic acid intervention on the patients of Alzheimer's disease by DNA methylation
download

注册号:

Registration number:

ChiCTR-TRC-13003246 

最近更新日期:

Date of Last Refreshed on:

2016-02-07 

注册时间:

Date of Registration:

2013-05-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于DNA甲基化途径叶酸对阿尔茨海默病作用机制的研究 

Public title:

Effects of folic acid intervention on the patients of Alzheimer's disease by DNA methylation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于DNA甲基化途径叶酸对阿尔茨海默病作用机制的研究 

Scientific title:

Effects of folic acid intervention on the patients of Alzheimer's disease by DNA methylation 

研究课题代号(代码):

Study subject ID:

81130053(National Natural Science Foundation of China) 

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:

马菲 

研究负责人:

黄国伟 

Applicant:

Fei Ma 

Study leader:

Guowei Huang 

申请注册联系人电话:

Applicant telephone:

+86 13821563872 

研究负责人电话:

Study leader's telephone:

+86-22-83336606 

申请注册联系人传真 :

Applicant Fax:

+86-22-83336603 

研究负责人传真:

Study leader's fax:

+86-22-83336603 

申请注册联系人电子邮件:

Applicant E-mail:

mf2002245mf@yahoo.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

huangguowei@tmu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.tmu.edu.cn/ggwsxy/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.tmu.edu.cn/ggwsxy/ 

申请注册联系人通讯地址:

天津市和平区气象台路22号天津医科大学公共卫生学院 

研究负责人通讯地址:

天津市和平区气象台路22号天津医科大学公共卫生学院 

Applicant address:

School of Public Health, Tianjin Medical University, 22 Qixiangtai Road, Heping District, Tianjin, China 

Study leader's address:

School of Public Health, Tianjin Medical University, 22 Qixiangtai Road, Heping District, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

300070 

研究负责人邮政编码:

Study leader's postcode:

300070 

申请人所在单位:

天津医科大学 

Applicant's institution:

Tianjin Medical 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:

20110301 

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:

天津医科大学医学伦理委员会 

Name of the ethic committee:

The Ethics Committee of Tianjin Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-03-01 

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:

天津医科大学 

Primary sponsor:

Tianjin Medical University 

研究实施负责(组长)单位地址:

天津市和平区气象台路号天津医科大学公共卫生学院 

Primary sponsor's address:

School of Public Health, Tianjin Medical University, 22 Qixiangtai Road, Heping District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津医科大学

具体地址:

天津市和平区气象台路22号

Institution
hospital:

Tianjin Medical University

Address:

22 Qixiangtai Road, Heping District, Tianjin, China

经费或物资来源:

国家自然基金重点项目资助(项目编号:81130053) 

Source(s) of funding:

National Natural Science Foundation of China (81130053) 

研究疾病:

阿尔茨海默病 

Target disease:

Alzheimer's disease (AD) 

研究疾病代码:

ICD:G30 

Target disease code:

ICD:G30 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

探讨基于DNA甲基化途径叶酸对阿尔茨海默病患者干预的作用机制。 

Objectives of Study:

To explore the effects of folic acid intervention on the patients of Alzheimer's disease by DNA methylation. 

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:

(1)符合美国国立老化研究所和阿尔茨海默病协会2011年修订的NIA-AA标准的很可能AD诊断标准。分别由2名神经内科的专业医师确诊;(2)均进行详细的病史询问、神经系统体检、神经心理测验、PET、MRI以及必要的实验室检查;(3)以汉语为母语,右利手,神志清楚,合作;(4)年龄40~90岁。 

Inclusion criteria

1. Patients meet a probable Alzheimers disease of NIA-AA diagnostic criteria in 2011 who were diagnosed by 2 neurology physician; 2. All were examined detailed history, neurologic examination, neuropsychological test, PET, MRI and the necessary laboratory examination; 3. All were native Chinese, right-handed, sane and cooperative; 4. Aged from 40 to 90 years old. 

排除标准:

①神经系统检查明显偏瘫、偏身感觉障碍、失语等局灶性中枢神经障碍体征,脑血管病史(包括出血性和缺血性),发生内脑外伤或骨折; ②喘息性支气管炎、严重高血压、心绞痛及严重感染等内科疾病; ③明显抑郁、焦虑情绪等精神病患者及其它内分泌系统疾病史(如甲亢、甲状腺功能低下、系统性红斑狼疮、类风湿关节炎等); ④新发现、进展期或晚期肿瘤; ⑤明显影响认知功能测试的视觉、听觉障碍或语言交流困难; ⑥酒精依赖及其他精神活性物质滥用病史(如抗精神病药、苯二氮卓类药等),或服用影响认知功能药物 

Exclusion criteria:

1. Neurological examination found the sign of local central nerve obstruction such as obvious paralysisunilateral sensory disturbance and aphasia etc, history of cerebrovascular diseases (hemorrhagic and ischemic stroke), brain injury or bone fracture; 2. Medical diseases such as asthmatic bronchitis, severe hypertension, angina pectoris and severe infection; 3. Psychotic patients with evident anxiety and depressed emotion and subjects with endocrine system history of disease(hyperthyroidism, thyroid hypofunction, systemic lupus eythematosus, rheumatoid arthritis); 4. Newly discovered or advanced tumor; 5. Visual perception, auditory perceptual disorders or languages communication difficulties, all of which may influence measurement of cognitive function; 6. Alcohol dependence and other psychoactive substance abuse such as antipsychotic drug,benzodiazepines or taking medicine influencing cognitive function. 

研究实施时间:

Study execute time:

From2012-01-01To 2016-12-31 

征募观察对象时间:

Recruiting time:

From2013-06-01To 2014-09-21 

干预措施:

Interventions:

组别:

AD干预组

样本量:

60

Group:

AD intervention group

Sample size:

干预措施:

督促服用叶酸1.25mg/天,口服,6个月

干预措施代码:

Intervention:

folic acid, 1.25mg/day, oral, six months

Intervention code:

组别:

对照

样本量:

60

Group:

control

Sample size:

干预措施:

不服用叶酸

干预措施代码:

Intervention:

without folic acid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津市 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市环湖医院 

单位级别:

三甲医院 

Institution
hospital:

ianjin Huanhu Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

血中相关基因表达水平

指标类型:

主要指标 

Outcome:

Blood gene expression related

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清叶酸,血浆同型半胱氨酸、S-腺苷甲硫氨酸、S-腺苷同型半胱氨酸

指标类型:

主要指标 

Outcome:

serum folate, plasma homocysteine, S-adenosyl homocysteine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MMSE、ADL量表评估分值

指标类型:

主要指标 

Outcome:

MMSE scores, ADL scale

Type:

Primary 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 40 years
最大 Max age 90 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):

对本研究不知情统计分析人员,采用随机数字法

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

statistics analyst ignorant to this study uses random number table

盲法:

采用单盲法,就是仅对负责设计的研究者设盲

Blinding:

Using single blind method, it is only for researchers who response for design

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

天津医科大学

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

Tianjin Medical University

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:

天津医科大学

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

Tianjin Medical University

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:

 2013-05-04
return list