| Trial ID: | L0565 |
| Source ID: | NCT01384539
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01384539/results
|
| Conditions: |
Arterial Dysfunction|Chronic Kidney Disease
|
| Interventions: |
DRUG: Cholecalciferol|DRUG: Calcitriol
|
| Outcome Measures: |
Primary: 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., 6 months | Secondary: 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, 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., 6 months
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
128
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-07
|
| Completion Date: |
2015-09
|
| Results First Posted: |
2017-08-17
|
| Last Update Posted: |
2018-09-28
|
| Locations: |
University of Colorado Denver Clinical Translational Research Center, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01384539
|
