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Completed

NCT Number: NCT01570309

Vitamin D Repletion in 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.

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Key information

Conditions

Vitamin D Deficiency Arterial Occlusive Diseases Arteriosclerosis Avitaminosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Deficiency Diseases Endothelial Dysfunction Heart Diseases Inflammation Malnutrition Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacobi Medical Center, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergocalciferol

Drug

Oral capsule, 50,000 units, once a week, 12 weeks

Sugar Pill

Other

Oral capsule, once a week, 12 weeks

Primary outcomes

  1. Endothelial Function

    Time frame: Baseline and 12 weeks

    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.

  2. Inflammation -

    Time frame: Baseline and 12 weeks

    Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups

  3. Inflammation

    Time frame: Baseline to 12 weeks

    Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups

  4. Inflammation

    Time frame: Baseline to 12 weeks

    Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups

  5. Inflammation

    Time frame: Baseline to week 12

    Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups

Sponsors and collaborators

Lead sponsor

Seth I. Sokol, M.D.

Other

Collaborators

  • Albert Einstein College of Medicine
  • American Heart Association
  • Jacobi Medical Center
  • Montefiore Medical Center
  • Yale University

Registry information

Official study title

The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 4, 2012
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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