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

March 26, 2012
August 5, 2013
August 2008
March 2011   (final data collection date for primary outcome measure)
  • Endothelial Function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
  • Inflammation - [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
  • Inflammation [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
  • Inflammation [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
  • Inflammation [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
  • Inflammation [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in blood levels of hs-CRP, interleukin-12, interferon-gamma, CXCL-10, e-selectin, s-VCAM, s-ICAM
  • Endothelial function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry
Complete list of historical versions of study NCT01570309 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
Not Provided
 
Vitamin D Repletion in Coronary Artery Disease
The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease

Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.

The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.

100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Coronary Artery Disease
  • Endothelial Dysfunction
  • Inflammation
  • Drug: Ergocalciferol
    Oral capsule, 50,000 units, once a week, 12 weeks
  • Other: Sugar pill
    Oral capsule, once a week, 12 weeks
  • Active Comparator: Ergocalciferol
    50,000 units of ergocalciferol once a week for 12 weeks
    Intervention: Drug: Ergocalciferol
  • Placebo Comparator: Sugar pill
    Intervention: Other: Sugar pill
Sokol SI, Srinivas V, Crandall JP, Kim M, Tellides G, Lebastchi AH, Yu Y, Gupta AK, Alderman MH. The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease. Vasc Med. 2012 Dec;17(6):394-404. doi: 10.1177/1358863X12466709. Erratum in: Vasc Med. 2013 Feb;18(1):51. Lebastchi, Amir [corrected to Lebastchi, Amir H].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and nonpregnant females greater than 18 years of age
  • ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
  • Serum 25-hydroxyvitamin D < 20 ng/ml

Exclusion Criteria:

  • confinement to a nursing facility, institution or home
  • GFR < 60 ml/min (by MDRD equation)
  • presence of liver disease
  • hypercalcemia
  • NYHA class III or IV heart failure
  • cardiogenic shock at time of presentation
  • current planned or emergent CABG
  • prior gastric or small bowel surgery
  • pancreatitis
  • malabsorption
  • inflammatory bowel disease
  • autoimmune disease
  • active malignancy
  • current use of > 800 IU/day of vitamin D
  • Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01570309
AHA Award #0885041N
No
Seth I. Sokol, M.D., New York City Health and Hospitals Corporation
Seth I. Sokol, M.D.
  • American Heart Association
  • Jacobi Medical Center
  • Albert Einstein College of Medicine of Yeshiva University
  • Yale University
  • Montefiore Medical Center
Principal Investigator: Seth I Sokol, MD Jacobi Medical Center
New York City Health and Hospitals Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP