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Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384539
First Posted: June 29, 2011
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: July 14, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cholecalciferol

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

Cholecalciferol

Calcitriol

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

Calcitriol


Participant Flow:   Overall Study
    Cholecalciferol   Calcitriol
STARTED   64   64 
COMPLETED   58   57 
NOT COMPLETED   6   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cholecalciferol

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

Cholecalciferol

Calcitriol

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

Calcitriol

Total Total of all reporting groups

Baseline Measures
   Cholecalciferol   Calcitriol   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   64   128 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (13)   59  (12)   58  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  29.7%      23  35.9%      42  32.8% 
Male      45  70.3%      41  64.1%      86  67.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Non-Hispanic White   23   23   46 
Non-Hispanic Black   18   14   32 
Hispanic   16   23   39 


  Outcome Measures

1.  Primary:   Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.   [ Time Frame: 6 months ]

2.  Secondary:   To Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   To Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: Jessica.Kendrick@ucdenver.edu



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: August 17, 2017