Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

Chronic Kidney Disease Clinical Trial

Official title: Response of Secondary Hyperparathyroidism to Paricalcitol Versus Ergocalciferol in Patients With Stage 3 and 4 Chronic Kidney Disease With Vitamin D Deficiency: a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.

Clinical Trial Description

This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines. Patients will be randomized to receive oral daily ergocalciferol or paricalcitol. A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism
• Vitamin D Deficiency

• NCT number: NCT00958451
• Study type: Interventional
• Source: Salem Veterans Affairs Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: July 2009
• Completion date: January 2011