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

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. Identifier: NCT01012414
Recruitment Status : Terminated (Futility in enrollment as of May 31, 2011)
First Posted : November 13, 2009
Results First Posted : November 11, 2013
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Chronic Kidney Disease
Hypovitaminosis D
Secondary Hyperparathyroidism
Interventions: Drug: paricalcitol
Drug: placebo

  Participant Flow

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
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
COMPLETED   0 [1] 
Withdrawal by Subject                2 
Lost to Follow-up                1 
Trial was stopped before completed                7 
[1] No subjects completed the study.

  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
Enrolled Total number participants consentedand enrolled

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   6 
[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

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

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

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

Responsible Party: Thomas Jefferson University Identifier: NCT01012414     History of Changes
Other Study ID Numbers: 09C.110
First Submitted: November 11, 2009
First Posted: November 13, 2009
Results First Submitted: May 30, 2013
Results First Posted: November 11, 2013
Last Update Posted: May 20, 2014