How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Duke University24 enrolled

Overview

Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperparathyroidism, Secondary Kidney Failure, Chronic

Interventions

doxercalciferolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage 5 Chronic Kidney Disease * Hyperparathyroidism (PTH\>300) requiring vitamin D therapy * Age 18-80 years old * Ability to provide informed consent Exclusion Criteria: * Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy * Subjects with contraindications or allergy to vitamin D * Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days * Serum phosphorus \> 6 * Serum calcium \> 10.5 * contraindications to nitroglycerin (such as being on sildenafil)

Locations (1)

Duke University Medical Center Dialysis Unit

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in Endothelial Cell Function

Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.

Time frame: 1 month

Data from ClinicalTrials.gov

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