Vitamin D Repletion in Coronary Artery Disease

NCT01570309 | Completed Results

• 1 other identifier: AHA Award #0885041N
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• Endothelial Function

  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.

  Baseline and 12 weeks

• Inflammation -

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

  Baseline and 12 weeks

• Inflammation

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

  Baseline to 12 weeks

• Inflammation

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

  Baseline to 12 weeks

• Inflammation

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

  Baseline to week 12

Study Arms (2)

Ergocalciferol

ACTIVE COMPARATOR

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

Drug: Ergocalciferol

Sugar pill

PLACEBO COMPARATOR

Other: Sugar pill

Interventions

Ergocalciferol DRUG

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

Ergocalciferol

Sugar pill OTHER

Oral capsule, once a week, 12 weeks

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seth I. Sokol, M.D.: lead
• American Heart Association: collaborator
• Jacobi Medical Center: collaborator
• Albert Einstein College of Medicine: collaborator
• Yale University: collaborator
• Montefiore Medical Center: collaborator

Study Sites (2)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center / Weiler division

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• 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.

  PMID: 23184900 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Coronary Artery Disease; Inflammation

Interventions

Ergocalciferols; Sugars

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Carbohydrates

Results Point of Contact

• Title: Dr Seth I Sokol
• Organization: Jacobi Medical Center

seth.sokol@nbhn.net

718-918-5735

Study Officials

• Seth I Sokol, MD

  Jacobi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: April 4, 2012
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 10, 2013
• Results First Posted: October 10, 2013

Record last verified: 2013-08

Locations

US (2)