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Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients (EVIDENCE)

Primary Purpose

Chronic Kidney Disease, Vitamin D Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitamin D2
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring The 25(OH) vitamin D level, The 1.25(OH) vitamin D level, The intact PTH level, The calcification score of coronary artery, The microalbuminuria level

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic kidney disease patients (3-5D)
  • serum 25（OH）D < 40nmol/L(16ng/ml)，serum calcium < 2.55mmol/L（10.2mg/dL）；
  • willing to sign
  • could obey the follow up design

Exclusion Criteria:

  • allergy to vitamin D
  • heart failure (NYHA more than 2 grade)
  • pregnant
  • malignant tumor
  • critical hepatic disease
  • taking Vitamin D or analogue in 3 recent months
  • taking other clinical trial

Sites / Locations

  • The People's Hospital of Peking UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treament

Control

Arm Description

Intervention Vitamin D2

Not take Vitamin D2

Outcomes

Primary Outcome Measures

the improvement of coronary artery calcification
We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。

Secondary Outcome Measures

the improvement of proteinuria
We detect the microalbuminuria in the chronic kidney disease patients for 5 times (baseline, 6 month,12 month 18month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。

Full Information

First Posted
August 21, 2012
Last Updated
August 29, 2012
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01672047
Brief Title
Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
Acronym
EVIDENCE
Official Title
Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.
Detailed Description
We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Vitamin D Deficiency
Keywords
The 25(OH) vitamin D level, The 1.25(OH) vitamin D level, The intact PTH level, The calcification score of coronary artery, The microalbuminuria level

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treament
Arm Type
Experimental
Arm Description
Intervention Vitamin D2
Arm Title
Control
Arm Type
No Intervention
Arm Description
Not take Vitamin D2
Intervention Type
Drug
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
Vitmain D2 capsule
Intervention Description
25（OH）D level <12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， >116.75nmol/L stopped.
Primary Outcome Measure Information:
Title
the improvement of coronary artery calcification
Description
We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the improvement of proteinuria
Description
We detect the microalbuminuria in the chronic kidney disease patients for 5 times (baseline, 6 month,12 month 18month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic kidney disease patients (3-5D) serum 25（OH）D < 40nmol/L(16ng/ml)，serum calcium < 2.55mmol/L（10.2mg/dL）； willing to sign could obey the follow up design Exclusion Criteria: allergy to vitamin D heart failure (NYHA more than 2 grade) pregnant malignant tumor critical hepatic disease taking Vitamin D or analogue in 3 recent months taking other clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Wang, MD, PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sui Zhun, MD
Phone
86-010-88325507
Email
suizhun@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wang Mei, MD
Phone
86-010-88325513
Email
wangmei@163.com
First Name & Middle Initial & Last Name & Degree
Wang Mei, MD

12. IPD Sharing Statement

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Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients

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