Back to resultsEffect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
Primary Purpose
Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Calcitriol
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease Stage 1 focused on measuring calcitrol, Bone mineral density, Osteoprotegin, Vascular calcification
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of CKD stage 1 and 2
- Age >18 years
- Ability to provide informed consent
Exclusion Criteria:
- On vitamin D in past 4 weeks
- Plans to relocate out of Taixing City in the next one year
- Serum phosphate >5.5 mg/dl in past 3 months
- Serum calcium >10.0 mg/dl in past 3 months
- Cancer
- Transplanted organ
- Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Sites / Locations
- Taixing People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
Calcitriol
Arm Description
Outcomes
Primary Outcome Measures
Osteoprotegin level
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
Secondary Outcome Measures
Bone mineral density
To assess the effect of vitamin D supplementation on bone mineral density in patients with CKD stage 1 and 2
vascular calcification score
To assess the effect of vitamin D supplementation on vascular calcification score through performing lateral abdominal radiography or CT-based techniques in patients with CKD stage 1 and 2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561222
Brief Title
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taixing People's Hospital
4. Oversight
5. Study Description
Brief Summary
Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
Keywords
calcitrol, Bone mineral density, Osteoprotegin, Vascular calcification
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
Calcitriol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Rocaltrol
Intervention Description
0.25 ug per day for one year
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one pill per day
Primary Outcome Measure Information:
Title
Osteoprotegin level
Description
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
Time Frame
one year
Secondary Outcome Measure Information:
Title
Bone mineral density
Description
To assess the effect of vitamin D supplementation on bone mineral density in patients with CKD stage 1 and 2
Time Frame
one year
Title
vascular calcification score
Description
To assess the effect of vitamin D supplementation on vascular calcification score through performing lateral abdominal radiography or CT-based techniques in patients with CKD stage 1 and 2
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of CKD stage 1 and 2
Age >18 years
Ability to provide informed consent
Exclusion Criteria:
On vitamin D in past 4 weeks
Plans to relocate out of Taixing City in the next one year
Serum phosphate >5.5 mg/dl in past 3 months
Serum calcium >10.0 mg/dl in past 3 months
Cancer
Transplanted organ
Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Zhang, Bachelor
Phone
008-613-905-266-789
Email
dr.zhangxu@tom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cai-xia Zhao, Master
Phone
008-615-896-079-628
Email
zhaocaixia2010@yahoo.cn
Facility Information:
Facility Name
Taixing People's Hospital
City
Taixing
State/Province
Jiangsu
ZIP/Postal Code
225400
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Zhang, bachelor
Phone
008-613-905-266-789
Email
dr.zhangxu@tom.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
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