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The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine - A randomized placebo controlled trial
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注册号:

Registration number:

ChiCTR-TRC-13003302 

最近更新日期:

Date of Last Refreshed on:

2016-02-10 

注册时间:

Date of Registration:

2013-07-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

服用維他命B為有輕度認知障礙和高〝同型半胱氨酸〞血漿水平的長者預防智力衰退 - 安慰劑隨機抽樣對照臨床研究 

Public title:

The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine - A randomized placebo controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

服用維他命B為有輕度認知障礙和高〝同型半胱氨酸〞血漿水平的長者預防智力衰退 - 安慰劑隨機抽樣對照臨床研究 

Scientific title:

The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine - A randomized placebo controlled trial 

研究课题代号(代码):

Study subject ID:

CRE_2012.175-T 

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:

CUHK_CCT00373 

申请注册联系人:

Hazel Mok 

研究负责人:

Prof. Timothy Kwok 

Applicant:

Hazel Mok 

Study leader:

Prof. Timothy Kwok 

申请注册联系人电话:

Applicant telephone:

+852 2632 3990 

研究负责人电话:

Study leader's telephone:

+852 2632 3145 

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:

hazelmok@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

tkwok@cuhk.edu.hk 

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:

Department of Medicine and Therapeutics, PWH 

研究负责人通讯地址:

Department of Medicine and Therapeutics, PWH 

Applicant address:

Department of Medicine and Therapeutics, PWH 

Study leader's address:

Department of Medicine and Therapeutics, PWH 

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:

The Chinese University of Hong Kong 

Applicant's institution:

The Chinese University of Hong Kong 

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:

Nil 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-06-06 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

RGC 

Source(s) of funding:

RGC 

研究疾病:

Dementia 

Target disease:

Dementia 

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:

上市后药物 

Study phase:

研究目的:

服用維他命B為有輕度認知障礙和高〝同型半胱氨酸〞血漿水平的長者預防智力衰退 

Objectives of Study:

The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine 

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. Aged elder than 70 years old; 2. Clinical diagnosis of MCI; 3. Homocysteine greater than 13umol/L; 4. Caregiver (personal contact at least once a week). 

Inclusion criteria

1. Aged elder than 70 years old; 2. Clinical diagnosis of MCI; 3. Homocysteine greater than 13umol/L; 4. Caregiver (personal contact at least once a week). 

排除标准:

1. Demenita; 2. Hypothyroidism; 3. B12 <150 pmol/L; 4. Folate <9.5 nmol/L; 5. Creatinine >200 umol/L. 

Exclusion criteria:

1. Demenita; 2. Hypothyroidism; 3. B12 <150 pmol/L; 4. Folate <9.5 nmol/L; 5. Creatinine >200 umol/L. 

研究实施时间:

Study execute time:

From2013-08-01To  

干预措施:

Interventions:

组别:

Two groups

样本量:

336

Group:

Two groups

Sample size:

干预措施:

Vitamin B12 and Folic acid for 24 months versus placebo

干预措施代码:

Intervention:

Vitamin B12 and Folic acid for 24 months versus placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Cognitive improvement (CDR score)

指标类型:

主要指标 

Outcome:

Cognitive improvement (CDR score)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CDR sum of scores

指标类型:

次要指标 

Outcome:

CDR sum of scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

neurocognitive test

指标类型:

次要指标 

Outcome:

neurocognitive test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

depression scale

指标类型:

次要指标 

Outcome:

depression scale

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 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):

RCT

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

RCT

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):

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:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-07-04
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