This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (>40 ng/mL) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. Half of the patients will be randomized to receive standard of care and half will receive clinical management of 25[OH] Vit D levels.
Low 25[OH] Vit D levels have become a public epidemic with increasing recognition of its widespread insufficiency both in the United States and worldwide. Epidemiologic studies have associated low 25[OH] Vit D levels with coronary risk factors and adverse cardiovascular outcomes. However, randomized trials are needed to establish the relevance of 25[OH] Vit D status to cardiovascular health. While a few randomized trials have evaluated vitamin D supplementation, none have "treated to target" (i.e., individual dosing so that adequate 25[OH] Vit D levels are obtained), but have rather given "blanket" doses regardless of 25[OH] Vit D level.
- Vitamin D3 Dietary Supplement
Other Names: cholecalciferol Intervention Desc: Vitamin D3 (cholecalciferol) will be provided to participants of the study. ARM 1: Kind: Experimental Label: Treatment Description: Patients randomized to the treatment arm will have a 25[OH] Vit D test performed, a sample taken and stored for future tests, and completion of a PHQ-9 depression survey. If 25[OH] Vit D is found to be >40 ng/mL, patients will then be contacted annually for continued 25[OH] Vit D testing and PHQ-9 completion. However, those with a 25[OH] Vit D level <40 ng/mL will initiate vitamin D3 supplementation or increase their current dose (if presently taking vitamin D3) based on the dosing protocol described below. Patients will then return in 3 months (±15 days) for follow-up 25[OH] Vit D testing. This will occur until a level of 25[OH] Vit D >40 has been obtained or until study conclusion as previously described. Outcomes will be determined through electronic records.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident||from date of randomization until the date of first documented event, up to 48 months|