Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Mahidol University

Status and phase: Unknown; Phase 2

Conditions: Vascular Calcification

Treatments: Drug: no drug; Drug: oral alfacalcidol

Study type: Interventional

Funder types: Other

Identifiers

NCT01364688

25-05-2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Treatment

Experimental group

Description:

oral alfacalcidol

Treatment:

Drug: oral alfacalcidol

Control

No Intervention group

Description:

No drug

Treatment:

Drug: no drug