Vitamin D Repletion in Coronary Artery Disease

NCT ID: NCT01570309

Last Updated: 2013-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Vitamin D Deficiency; Coronary Artery Disease; Endothelial Dysfunction; Inflammation

Keywords

vitamin D,; vitamin D deficiency; coronary artery disease; ergocalciferol; endothelial function; adhesion molecules; inflammation; IL-12; interferon-gamma; CXCL-10; reactive hyperemia peripheral arterial tonometry; endothelial dysfunction; cytokines; chemokines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ergocalciferol

50,000 units of ergocalciferol once a week for 12 weeks

Group Type: ACTIVE_COMPARATOR

Ergocalciferol

Intervention Type: DRUG

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

Sugar pill

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: OTHER

Oral capsule, once a week, 12 weeks

Interventions

Ergocalciferol

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

Intervention Type: DRUG

Sugar pill

Oral capsule, once a week, 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Jacobi Medical Center

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

Seth I. Sokol, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Seth I. Sokol, M.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seth I Sokol, MD

Role: PRINCIPAL_INVESTIGATOR

Jacobi Medical Center

Locations

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center / Weiler division

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23184900 (View on PubMed)

Other Identifiers

AHA Award #0885041N

Identifier Type: -

Identifier Source: org_study_id