Back to resultsOral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Primary Purpose
Vascular Calcification
Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
oral alfacalcidol
no drug
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Calcification focused on measuring coronary calcification, vascular calcification, active vitamin D, alfacalcidol
Eligibility Criteria
Inclusion Criteria:
- Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
- PTH above the upper limit of normal
- serum calcium and phosphate below the upper limit of normal
Exclusion Criteria:
- changes in GFR>15% during the past 3 months
- receive elemental calcium>500 mg/day
- currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate
Sites / Locations
- Faculty of Medicine, Ramathibodi Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
oral alfacalcidol
No drug
Outcomes
Primary Outcome Measures
Change in Coronary Artery Calcification
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364688
Brief Title
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Official Title
Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.
Detailed Description
Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Calcification
Keywords
coronary calcification, vascular calcification, active vitamin D, alfacalcidol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
oral alfacalcidol
Arm Title
Control
Arm Type
No Intervention
Arm Description
No drug
Intervention Type
Drug
Intervention Name(s)
oral alfacalcidol
Intervention Description
Oral alfacalcidol 0.5 microgram per day
Intervention Type
Drug
Intervention Name(s)
no drug
Intervention Description
no drug
Primary Outcome Measure Information:
Title
Change in Coronary Artery Calcification
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
PTH above the upper limit of normal
serum calcium and phosphate below the upper limit of normal
Exclusion Criteria:
changes in GFR>15% during the past 3 months
receive elemental calcium>500 mg/day
currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinee Disthabanchong, MD
Phone
+6622011116
Email
tesdb@mahidol.ac.th
Facility Information:
Facility Name
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
City
Phayathai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinee Disthabanchong, MD
Phone
+662011116
Email
tesdb@mahidol.ac.th
12. IPD Sharing Statement
Learn more about this trial
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
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