Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Ramathibodi Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Coronary Artery Calcification
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
oral alfacalcidol
Intervention: oral alfacalcidol (Drug)
Control
No drug
Intervention: no drug (Drug)
Outcomes
Primary Outcomes
Change in Coronary Artery Calcification
Time Frame: 6 months and 12 months
Secondary Outcomes
No secondary outcomes reported