Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Study Overview
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Brief Summary
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The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

Detailed Description
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The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

Official Title
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Role of Vitamin D in Secondary Prevention of Cardiovascular Events

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of age > 19 years at the time informed consent is signed. Subject with a diagnosis of unstable angina (with Thrombolysis in Myocardial Infarction (TIMI) score of greater than or equal to 3) / NSTEMI or STEMI,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion Subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment. Exclusion Criteria: Subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin D deficiency). Subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin D metabolism). Subject is on an investigational drug, which is a new drug class and not part of standard ACS protocol. Subject is taking supplements of vitamin D with doses >400 IU/day. Subject has hypersensitivity to vitamin D products. Subject has history of systemic lupus erythematosus (since vitamin D deficiency is common in this group27). Subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin D28) Subject has history of renal stones. Subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening. Subject has end stage renal disease, defined as either chronic kidney disease stage V or requiring dialysis (since these patients have altered vitamin D and calcium metabolism). Subject has systemic disease (including terminal cancer, cirrhosis, end stage COPD etc.,) with reduced (<12 months) life expectancy. Subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study. Subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study. Subject is pregnant.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D (cholecalciferol)<br>Subjects receive 150,000 IU of Vitamin D3 every 2 months | Dietary Supplement: Cholecalciferol<br>* cholecalciferol 150,000 IU by mouth every 2 months for 1 year<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3 | Dietary Supplement: Placebo<br>* placebo by mouth every 2 months for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml. |  | 1 year | 
| To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see if higher serum 25(OH) D levels will help in better control of blood pressure. |  | 1 year | 
| To perform proteomics analysis to: a) Extract total protein; b) Profile protein expression in 2-DE and /or 2-DLC and direct mass spectrometric analysis (dMS) on the serum of vitamin D supplemented and placebo subjects. |  | 1 year | 
| To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects. |  | 1 year | 
| To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Cardiac Catheterization, Cardiovascular event, Cardiovascular Disease