Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

University of Colorado, Denver128 enrolled

Overview

The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

128

Conditions

Arterial Dysfunction Chronic Kidney Disease

Interventions

CholecalciferolDRUG

CalcitriolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate \[GFR\] 44-15 ml/min/1.73m2) * Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level \< 30 ng/mL * Corrected serum calcium \< 10.2 mg/dL * Serum phosphate \< 4.6 mg/dL * Serum albumin \> 3.0 g/dL * Body mass index \< 40 kg/m2 * Ability to give informed consent Exclusion Criteria: * Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * Expected to undergo living related kidney transplant in next 6 months * Pregnant, breastfeeding, or unwilling to use adequate birth control * History of severe liver disease * Nephrotic range proteinuria (\> 3.5 gm/day) * Use of active vitamin D analogs within 30 days of randomization

Locations (1)

University of Colorado Denver Clinical Translational Research Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.

EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.

Time frame: 6 months

Secondary Outcomes

Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein

Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation

Time frame: 6 months

Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB

The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure.

Time frame: 6 months

Data from ClinicalTrials.gov

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