Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease (VINCA-CKD)

This study has been terminated.
(Futility in enrollment as of May 31, 2011)
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01012414
First received: November 11, 2009
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Chronic Kidney Disease
Hypovitaminosis D
Secondary Hyperparathyroidism
Interventions: Drug: paricalcitol
Drug: placebo

  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
The enrollment period began in November 2009. The first subject was emrolled June 17, 2010. The final subject (#12) was enrolled April 14, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 additional participants were in a washout period when the study was stopped. These participants were not enrolled or randomized.

Reporting Groups
  Description
All Participants The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.

Participant Flow:   Overall Study
    All Participants  
STARTED     10  
COMPLETED     0 [1]
NOT COMPLETED     10  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  
Trial was stopped before completed                 7  
[1] No subjects completed the study.



  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
Enrolled Total number participants consentedand enrolled

Baseline Measures
    Enrolled  
Number of Participants  
[units: participants]
  10  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     6  
Gender  
[units: Participants]
 
Female     3  
Male     7  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     9  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     4  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in High Sensitivity-C Reactive Protein (Serum)   [ Time Frame: 1 year ]

2.  Secondary:   Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A   [ Time Frame: 1 year ]

3.  Secondary:   Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.   [ Time Frame: 1 year ]

4.  Secondary:   Effect on Carotid Intima-media Thickening (CIMT)   [ Time Frame: 1 year ]


  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
Early termination secondary to enrollment futility.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Whellan MD
Organization: Thomas Jefferson University
phone: 215 955 5050
e-mail: david.whellan@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01012414     History of Changes
Other Study ID Numbers: 09C.110
Study First Received: November 11, 2009
Results First Received: May 30, 2013
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board