Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Phase 2

• Conditions: Vascular Calcification
• Interventions: Drug: oral alfacalcidol; Drug: no drug

• Registration Number: NCT01364688
• Lead Sponsor: Ramathibodi Hospital

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 Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	oral alfacalcidol	oral alfacalcidol
Control	no drug	No drug

Primary Outcome Measures

Name	Time	Method
Change in Coronary Artery Calcification	6 months and 12 months

Trial Locations

Locations (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University; 🇹🇭 Phayathai, Bangkok, Thailand