NCT02996721

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

A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Death
• Myocardial Infarction
• Cerebral Vascular Accident
• Heart Failure Hospitalization

Interventions

Type	Name	Description
BIOLOGICAL	Vitamin D3	Vitamin D3 (cholecalciferol) will be provided to participants of the study.

Timeline

• Start date: 2017-04-03
• Primary completion: 2025-03-30
• Completion: 2025-09-04
• First posted: 2016-12-19
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study