We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D and Coronary Calcification Study (VCOR)

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.
ClinicalTrials.gov Identifier: NCT00752102
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Chronic Kidney Disease
Vitamin D Deficiency
Coronary Calcification
Disorders of Calcium and Bone Metabolism
Interventions: Drug: Calcitriol (Rocaltrol®)
Drug: Paricalcitol

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Calcitriol Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
Paricalcitol Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.

Participant Flow:   Overall Study
    Calcitriol   Paricalcitol
STARTED   22   22 
COMPLETED   19   21 
NOT COMPLETED   3   1 



  Baseline Characteristics

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
Calcitriol Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
Paricalcitol Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
Total Total of all reporting groups

Baseline Measures
   Calcitriol   Paricalcitol   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Years]
Geometric Mean (Standard Deviation)
 65.8  (7.4)   65.5  (11)   65.6  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  22.7%      13  59.1%      18  40.9% 
Male      17  77.3%      9  40.9%      26  59.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      14  63.6%      15  68.2%      29  65.9% 
White      8  36.4%      7  31.8%      15  34.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   22   22   44 


  Outcome Measures

1.  Primary:   Coronary Artery (CAC) Score Progression   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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. Sylvia Rosas
Organization: Joslin Diabetes Center
phone: 617-309-2477
e-mail: sylvia.rosas@joslin.harvard.edu



Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00752102     History of Changes
Other Study ID Numbers: Abbott #20128
First Submitted: September 11, 2008
First Posted: September 15, 2008
Results First Submitted: August 24, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017