Vitamin D and Arterial Function in Patients With Chronic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:9/30/2018
Start Date:July 2011
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
University of Colorado Denver Clinical Translational Research Center
Aurora, Colorado 80045
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Aurora, CO
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