A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients "TARGET-D"

Recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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.

Outcomes

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

Sponsors