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

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.

Inclusion criteria

• Patients, both male and female, >18 years old
• Undergone angiography for a MI (troponin positive [>0.04 ng/mL] and ACS diagnosis) within the past month
• Receive follow-up care at an Intermountain Healthcare facility
• Not taking or taking <1000 IU of vitamin D daily within the last 3 months
• Willing to provide informed consent and participate in follow-up visits

Exclusion criteria

• Hypersensitivity to vitamin D products
• History of previous vitamin D supplementation of >1000 IU daily within the past 3 months (i.e., >40% of the days during the past 3 months).
• Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a reduced (<12 months) life expectancy
• Hypercalcemia (calcium levels >10.6 mg/dL)
• Subject participation in previous investigational interventional studies within 30 days of the current study.
• History of psychiatric illness/condition that would interfere with their ability to understand or complete the requirements of the study, a condition that in the opinion of the investigator or their designee places the subject at an unacceptable risk as a participant.
• Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception as determined by the clinical investigators.