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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01384539
Recruitment Status : Completed
First Posted : June 29, 2011
Results First Posted : August 17, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Arterial Dysfunction
Chronic Kidney Disease
Interventions Drug: Cholecalciferol
Drug: Calcitriol
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cholecalciferol Calcitriol
Hide Arm/Group Description

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

Period Title: Overall Study
Started 64 64
Completed 58 57
Not Completed 6 7
Arm/Group Title Cholecalciferol Calcitriol Total
Hide Arm/Group Description

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

Total of all reporting groups
Overall Number of Baseline Participants 64 64 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 64 participants 128 participants
58  (13) 59  (12) 58  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
Female
19
  29.7%
23
  35.9%
42
  32.8%
Male
45
  70.3%
41
  64.1%
86
  67.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
Non-Hispanic White
23
  35.9%
23
  35.9%
46
  35.9%
Non-Hispanic Black
18
  28.1%
14
  21.9%
32
  25.0%
Hispanic
16
  25.0%
23
  35.9%
39
  30.5%
1.Primary Outcome
Title Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol Calcitriol
Hide Arm/Group Description:

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

Overall Number of Participants Analyzed 58 57
Mean (Standard Deviation)
Unit of Measure: percent change in FMD
-0.5  (4.2) 0.3  (3.5)
2.Secondary Outcome
Title Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
Hide Description Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol Calcitriol
Hide Arm/Group Description:

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

Overall Number of Participants Analyzed 58 57
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
3.0
(1.2 to 7.9)
3.4
(1.5 to 6.7)
End of Study
3.1
(1.7 to 8.3)
3.9
(0.3 to 2.1)
3.Secondary Outcome
Title Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol Calcitriol
Hide Arm/Group Description:

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

Overall Number of Participants Analyzed 58 57
Mean (Standard Deviation)
Unit of Measure: ratio of NFkB to HUVEC expression
0.03  (0.1) -0.01  (0.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cholecalciferol Calcitriol
Hide Arm/Group Description

Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol

Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol

All-Cause Mortality
Cholecalciferol Calcitriol
Affected / at Risk (%) Affected / at Risk (%)
Total   2/64 (3.13%)      0/64 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cholecalciferol Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/64 (14.06%)      5/64 (7.81%)    
Cardiac disorders     
Hospitalization [1]  9/64 (14.06%)  9 5/64 (7.81%)  5
[1]
Hospitalization for congestive heart failure, myocardial infarction, stroke, and/or angina
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cholecalciferol Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/64 (1.56%)      4/64 (6.25%)    
Renal and urinary disorders     
Hypercalcemia  1/64 (1.56%)  1 4/64 (6.25%)  4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jessica Kendrick
Organization: University of Colorado
Phone: 303-602-5012
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01384539     History of Changes
Other Study ID Numbers: 11-0521
5K23DK087859 ( U.S. NIH Grant/Contract )
First Submitted: June 27, 2011
First Posted: June 29, 2011
Results First Submitted: July 14, 2017
Results First Posted: August 17, 2017
Last Update Posted: September 28, 2018