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发育行为问题及疾病儿童营养状况调查及干预
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注册号:

Registration number:

ChiCTR-OPC-17013502 

最近更新日期:

Date of Last Refreshed on:

2018-11-08 

注册时间:

Date of Registration:

2017-11-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

发育行为问题及疾病儿童营养状况调查及干预 

Public title:

nutritional status investigation and intervention of children with Developmental behavioral problems and disease  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

发育行为问题及疾病儿童营养状况调查及干预 

Scientific title:

nutritional status investigation and intervention of children with Developmental behavioral problems and disease  

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:

李洪华 

研究负责人:

贾飞勇 

Applicant:

Honghua Li 

Study leader:

Feiyong Jia 

申请注册联系人电话:

Applicant telephone:

+86 0431-88783846 

研究负责人电话:

Study leader's telephone:

+86 0431-88783846 

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:

ttian_2332@163.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:

中国吉林省长春市朝阳区新民大街71号吉大一院发育行为儿科 

研究负责人通讯地址:

中国吉林省长春市朝阳区新民大街71号 

Applicant address:

71 Xinmin Avenue, Chaoyang District, Changchun, Jilin, China 

Study leader's address:

71 Xinmin Avenue, Chaoyang District, Changchun, Jilin, China 

申请注册联系人邮政编码:

Applicant postcode:

130021 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

吉林大学第一医院 

Applicant's institution:

Department of Developmental and Behavioral Pediatrics, 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:

2017-314 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

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 Jilin University First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-29 

伦理委员会联系人:

赵丽媛 

Contact Name of the ethic committee:

Zhao Liyuan 

伦理委员会联系地址:

中国吉林省长春市朝阳区新民大街71号吉大一院 

Contact Address of the ethic committee:

71 Xinmin Avenue, Chaoyang District, Changchun, Jilin, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0431 88782053 

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:

吉林大学第一医院 

Primary sponsor:

First Hospital of Jilin University 

研究实施负责(组长)单位地址:

中国吉林省长春市朝阳区新民大街71号 

Primary sponsor's address:

71 Xinmin Avenue, Chaoyang District, Changchun, Jilin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

发育行为问题及疾病 

Target disease:

Developmental behavioral problems and disease  

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:

上市后药物 

Study phase:

研究目的:

1、检测发育行为问题及发育行为疾病血清脂溶性维生素与微量元素的水平。 2、分析发育行为疾病患儿脂溶性维生素、微量元素水平及症状之间的相关关系。 3、观察营养干预对发育行为问题及发育行为疾病的效果。 

Objectives of Study:

1. To examine serum levels of fat-soluble vitamins and trace elements of children with Developmental behavioral problems and disease; 2. To analyze the correlation between the symptoms of Developmental behavioral disease and the level of fat-soluble vitamins and trace elements; 3. To observe th effect of the nutrition intervention on Developmental behavioral problems and disease.  

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:

①存在发育行为问题及疾病的儿童;明确诊断ID的患儿,年龄4-10岁;ASD患儿年龄2-6岁;ADHD患儿,年龄6-16岁;TD患儿,年龄6-16岁;②近期正常参加户外活动接受光照及正常膳食者;③未接受过营养素制剂补充者;④患儿监护人知情同意接受本临床试验者; 

Inclusion criteria

(1) Children with developmental behavioral problems and disease: children with Diagnosis of ID, ages 4 to 10 years old;Children with ASD age 2 to 6 years old,children with ADHD, ages 6 to 16 years old;children with TD, aged 6 to 16 years old; (2) in the near future to participate in outdoor activities with light and normal normal diet; (3) not received supplementary nutrients preparations; (4) Signed informed consent by the child guardian. 

排除标准:

(1)明确头外伤史、神经系统疾病和严重躯体疾病史者;(2)伴有尚未控制的癫痫发作的患儿;(3)患者监护人拒绝接受电话随访或复诊者。 

Exclusion criteria:

(1) clear head trauma history, history of nervous system diseases and serious body disease; (2) children who have not control the seizures; (3) patients with guardian refused to accept telephone follow-up or appointment. 

研究实施时间:

Study execute time:

From2017-12-01To 2018-12-01 

征募观察对象时间:

Recruiting time:

From2017-12-01To 2018-12-01 

干预措施:

Interventions:

组别:

智力障碍组

样本量:

60

Group:

group A

Sample size:

干预措施:

维生素A、D,锌,铁

干预措施代码:

Intervention:

vitamin A, D, zinc, iron

Intervention code:

组别:

抽动障碍组

样本量:

60

Group:

group B

Sample size:

干预措施:

补充维生素A、D,锌,铁

干预措施代码:

Intervention:

vitamin A, D, zinc, iron

Intervention code:

组别:

多动障碍组

样本量:

60

Group:

group C

Sample size:

干预措施:

维生素A、D,锌,铁

干预措施代码:

Intervention:

vitamin A, D, zinc, iron

Intervention code:

组别:

孤独症谱系障碍i组

样本量:

60

Group:

group D

Sample size:

干预措施:

维生素A、D,锌,铁

干预措施代码:

Intervention:

vitamin A, D, zinc, iron

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):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Hospital of Jilin University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

耶鲁综合抽动严重程度量表

指标类型:

主要指标 

Outcome:

YGTSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多动症评定量表

指标类型:

主要指标 

Outcome:

SNAP-IV

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会适应能力量表

指标类型:

次要指标 

Outcome:

SM

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会交往能力量表

指标类型:

次要指标 

Outcome:

SRS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

格里菲斯发育诊断量表

指标类型:

主要指标 

Outcome:

Griffiths

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症行为量表

指标类型:

主要指标 

Outcome:

ABC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症评定量表

指标类型:

主要指标 

Outcome:

CARS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症症状评定量表

指标类型:

主要指标 

Outcome:

ATEC

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 2 years
最大 Max age 16 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):

研究人员用EXCLE产生随机数表

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

Computer software

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

点击下载

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

download

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:

两人负责数据采集与管理,分别记录研究对象CRF表,当两个人记录结果一致时才能采用该数据,保证了数据真实可靠。

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-11-23
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