Back to resultsVitamin D and Arterial Function in Patients With Chronic Kidney Disease
Primary Purpose
Arterial Dysfunction, Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Calcitriol
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Dysfunction focused on measuring chronic kidney disease, vitamin D deficiency
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 < 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
Sites / Locations
- University of Colorado Denver Clinical Translational Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cholecalciferol
Calcitriol
Arm Description
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01384539
First Posted
June 27, 2011
Last Updated
August 30, 2018
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01384539
Brief Title
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Official Title
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Dysfunction, Chronic Kidney Disease
Keywords
chronic kidney disease, vitamin D deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Arm Title
Calcitriol
Arm Type
Experimental
Arm Description
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Primary Outcome Measure Information:
Title
Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
Description
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 Outcome Measure Information:
Title
Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
Description
Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
Time Frame
6 months
Title
Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Kendrick, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver Clinical Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
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