Vitamin D Repletion in Coronary Artery Disease

This study has been completed.
Sponsor:
Collaborators:
American Heart Association
Jacobi Medical Center
Albert Einstein College of Medicine of Yeshiva University
Yale University
Montefiore Medical Center
Information provided by (Responsible Party):
Seth I. Sokol, M.D., New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier:
NCT01570309
First received: March 26, 2012
Last updated: August 5, 2013
Last verified: August 2013
Results First Received: September 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Vitamin D Deficiency
Coronary Artery Disease
Endothelial Dysfunction
Inflammation
Interventions: Drug: Ergocalciferol
Other: Sugar pill

  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
Recruitment from October 2008 through December 2010 from the cardiac catheterization laboratories and outpatient clinics of the Jacobi Medical Center and Montefiore Medical Center in the Northeastern section of the Bronx, NY. Additional recruitment occurred at Crystal Run Health in Orange County, NY.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization, were screened for vitamin D deficiency by measurement of serum 25-hydroxyvitamin D (25-vitamin D).Eligible subjects with a 25-vitamin D level < 20 ng/ml were randomly assigned 1:1 to active or placebo treatment

Reporting Groups
  Description
Ergocalciferol 50,000 units of ergocalciferol once a week for 12 weeks
Sugar Pill Matching placebo

Participant Flow:   Overall Study
    Ergocalciferol     Sugar Pill  
STARTED     48     48  
COMPLETED     45     45  
NOT COMPLETED     3     3  
Withdrawal by Subject                 3                 3  



  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
Ergocalciferol 50,000 units of ergocalciferol once a week for 12 weeks
Sugar Pill Matching placebo
Total Total of all reporting groups

Baseline Measures
    Ergocalciferol     Sugar Pill     Total  
Number of Participants  
[units: participants]
  48     48     96  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     43     35     78  
>=65 years     5     13     18  
Age  
[units: years]
Mean ± Standard Deviation
  54.6  ± 9.5     56.5  ± 11.7     55.6  ± 10.6  
Gender  
[units: participants]
     
Female     9     15     24  
Male     39     33     72  
Region of Enrollment  
[units: participants]
     
United States     48     48     96  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Endothelial Function   [ Time Frame: Baseline and 12 weeks ]

2.  Primary:   Inflammation -   [ Time Frame: Baseline and 12 weeks ]

3.  Primary:   Inflammation   [ Time Frame: Baseline to 12 weeks ]

4.  Primary:   Inflammation   [ Time Frame: Baseline to 12 weeks ]

5.  Primary:   Inflammation   [ Time Frame: Baseline to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Dr Seth I Sokol
Organization: Jacobi Medical Center
phone: 718-918-5735
e-mail: seth.sokol@nbhn.net


Publications of Results:

Responsible Party: Seth I. Sokol, M.D., New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT01570309     History of Changes
Other Study ID Numbers: AHA Award #0885041N
Study First Received: March 26, 2012
Results First Received: September 23, 2012
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board