Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Ramathibodi Hospital80 enrolled

Overview

Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vascular Calcification

Interventions

oral alfacalcidolDRUG

Oral alfacalcidol 0.5 microgram per day

no drugDRUG

no drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Phayathai, Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Change in Coronary Artery Calcification

Time frame: 6 months and 12 months

Central Contacts

Sinee Disthabanchong, MD

CONTACT

+6622011116 tesdb@mahidol.ac.th

Data from ClinicalTrials.gov

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