ChiCTR2100045116 版本V1.0 版本创建时间2021/04/07 04:21:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100045116 

最近更新日期：

Date of Last Refreshed on：

 2021-04-07 04:20:37 

注册时间：

Date of Registration：

 2021-04-07 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

Public title：

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

Scientific title：

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney 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：

Muhammad Abbas Abid 

研究负责人：

Dr Aysha Habib 

Applicant：

Muhammad Abbas Abid 

Study leader：

Dr Aysha Habib 

申请注册联系人电话：

Applicant telephone：

 +92 21 34861927

研究负责人电话：

Study leader's
telephone：

+92 21 34861927

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：

 abbas.abid@aku.edu

研究负责人电子邮件：

Study leader's E-mail：

 aysha.habib@aku.edu

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：

Aga Khan University, Karachi, Pakistan

研究负责人通讯地址：

Aga Khan University, Karachi, Pakistan

Applicant address：

Aga Khan University, Karachi, Pakistan

Study leader's address：

Aga Khan University, Karachi, Pakistan

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：

巴基斯坦卡拉奇Aga Khan University

Applicant's institution：

Aga Khan University

研究负责人所在单位：

巴基斯坦卡拉奇Aga Khan University

Affiliation of the Leader：

Aga Khan 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：

 1624-Med-ERC-10

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：

Ethical Review Committee

Name of the ethic committee：

Ethical Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2011-02-18 00:00:00

伦理委员会联系人：

S Q Nizami

Contact Name of the ethic committee：

S Q Nizami

伦理委员会联系地址：

巴基斯坦卡拉奇Aga Khan University

Contact Address of the ethic committee：

Aga Khan University, Karachi, Pakistan

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：

None

Primary sponsor：

None

研究实施负责（组长）单位地址：

None

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Chronic kidney disease  

Target disease：

Chronic kidney disease

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：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

Aims of the study: To assess the improvement in musculoskeletal health in individuals with chronic kidney disease having 25 OH vitamin D deficiency by giving vitamin D3 (cholecalciferol) and increased physical therapy. Primary Objectives: To compare improvement in objective measure of musculoskeletal health as assessed by hand grip measure in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. To compare the improvement in physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy based on subjective questionnaires. To compare differences in musculoskeletal health as measured by change in muscular strength and physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. Secondary Objectives: To assess the improvement in serum 25OH vitamin D levels among patients with Chronic Kidney disease with vitamin D3 supplementations.  

Objectives of Study：

Aims of the study: To assess the improvement in musculoskeletal health in individuals with chronic kidney disease having 25 OH vitamin D deficiency by giving vitamin D3 (cholecalciferol) and increased physical therapy. Primary Objectives: To compare improvement in objective measure of musculoskeletal health as assessed by hand grip measure in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. To compare the improvement in physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy based on subjective questionnaires. To compare differences in musculoskeletal health as measured by change in muscular strength and physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. Secondary Objectives: To assess the improvement in serum 25OH vitamin D levels among patients with Chronic Kidney disease with vitamin D3 supplementations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Treatment Regimen: Vitamin D3 (cholecalciferol), 4000 IU once daily orally in both the study arms.  

纳入标准：

1. Patients aged 20 to 60 years;
2. CKD stage 2-4;
3. Patients with CKD and having creatinine of >=1.7 mg/dL for men and >=1.4 mg/dL for women will be screened;
4. Vitamin D deficient subjects (<=20 nmol/L) (32);
5. Able to provide written informed consent.

Inclusion criteria

1. Patients aged 20 to 60 years;
2. CKD stage 2-4;
3. Patients with CKD and having creatinine of >=1.7 mg/dL for men and >=1.4 mg/dL for women will be screened;
4. Vitamin D deficient subjects (<=20 nmol/L) (32);
5. Able to provide written informed consent.

排除标准：

1. Patients with any transplant (due to use of immune-suppression);
2. Patients with CKD 5 or ESRD;
3. Patients receiving dialysis;
4. Patients who are under treatment for Vitamin D deficiency;
5. Patients who have some sort of known vitamin D deficiency related bone disease by history;
6. Subjects already maintained on steroids;
7. Patients Who Have Been On (25 Or 1, 25, OH Vitamin D Supplementation for Vitamin D Repletion- I/M in last One Year;
8. Patients with known chronic inflammatory disease, malignancy;
9. Subjects who cannot perform physical activity due to any disability or limiting condition;
10. Patients with known depression;
11. Patients with calcium and phosphorus product of > 70 mg/dl.

Exclusion criteria：

1. Patients with any transplant (due to use of immune-suppression);
2. Patients with CKD 5 or ESRD;
3. Patients receiving dialysis;
4. Patients who are under treatment for Vitamin D deficiency;
5. Patients who have some sort of known vitamin D deficiency related bone disease by history;
6. Subjects already maintained on steroids;
7. Patients Who Have Been On (25 Or 1, 25, OH Vitamin D Supplementation for Vitamin D Repletion- I/M in last One Year;
8. Patients with known chronic inflammatory disease, malignancy;
9. Subjects who cannot perform physical activity due to any disability or limiting condition;
10. Patients with known depression;
11. Patients with calcium and phosphorus product of > 70 mg/dl.

研究实施时间：

Study execute time：

从 From 2012-01-01 00:00:00至 To 2016-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2013-11-01 00:00:00 至 To 2014-10-30 00:00:00

干预措施：

Interventions：

组别：

Intervention

样本量：

 28

Group：

Intervention

Sample size：

干预措施：

Oral Vitamin D plus physical activity

干预措施代码：

Intervention：

Oral Vitamin D plus physical activity

Intervention code：

组别：

Control

样本量：

 18

Group：

Control

Sample size：

干预措施：

Oral Vitamin D

干预措施代码：

Intervention：

Oral Vitamin D

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 信德 

市(区县)：

 卡拉奇 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 Aga Khan University 

单位级别：

 三级 

Institution
hospital：

Aga Khan University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Musculoskeletal strength

指标类型：

主要指标

Outcome：

Musculoskeletal strength

Type：

Primary indicator

测量时间点：

测量方法：

MicroFit System

Measure time point of outcome：

Measure method：

MicroFit System

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

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 20 岁 years
最大 Max age 60 岁 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）：

Randomization will be performed via computer generated random numbers by a statistician. A block randomization strategy with individual blocks with varying multiples of 4 will be used to periodically balance the assignment in the 2 study arms. Randomization lists will be stratified by Hospitals (AKUH and kidney

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

Randomization will be performed via computer generated random numbers by a statistician. A block randomization strategy with individual blocks with varying multiples of 4 will be used to periodically balance the assignment in the 2 study arms. Randomization lists will be stratified by Hospitals (AKUH and kidney

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

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）：

Findings will be published in International Research journals

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

Findings will be published in International Research journals

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 collected will be entered in SPSS and analysis will be completed. All data will be saved in password protected computers and only the PI will have access to all the data.

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

Data collected will be entered in SPSS and analysis will be completed. All data will be saved in password protected computers and only the PI will have access to all the data.

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：

  2021-04-07 04:20:37