Phase 3
N=128
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Arterial Dysfunction · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01384539 ↗Enrolled (actual)
128
Serious AEs
10.9%
Results posted
Aug 2017
Primary outcome: Primary: Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment. — -0.5; 0.3 percent change in FMD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cholecalciferol (Drug); Calcitriol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment. |
-0.5; 0.3 | — |
| SECONDARY Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein |
3.0; 3.4; 3.1; 3.9 | — |
| SECONDARY Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB |
0.03; -0.01 | — |
Summary
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.
Eligibility Criteria
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 3.0 g/dL
- Body mass index 3.5 gm/day)
- Use of active vitamin D analogs within 30 days of randomization
Data sourced from ClinicalTrials.gov (NCT01384539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.