Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Completed · Phase 3

Conditions studied: Arterial Dysfunction, Chronic Kidney Disease

In brief

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.

Key facts

Study ID: NCT01384539
Run by: University of Colorado, Denver
People needed: 128
Starts: 2011-07-01
Expected to finish: 2015-09-01
Last updated by the study team: 2018-09-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Colorado Denver Clinical Translational Research Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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