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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    890
  • sponsor
    Intermountain Health Care, Inc.
Updated on 15 April 2021
angiography
infarct
troponin

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.

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.

Details
Condition Death, Cerebrovascular accident, Myocardial Infarction, Ischemic Heart Disease, Heart Attack (Myocardial Infarction), Heart Failure Hospitalization, Stroke, Cardiac Ischemia, Myocardial Ischemia, heart attack, myocardial infarction (mi), cardiac infarction, heart attacks, myocardial necrosis, cerebrovascular accidents, strokes, cerebral
Treatment Vitamin D3
Clinical Study IdentifierNCT02996721
SponsorIntermountain Health Care, Inc.
Last Modified on15 April 2021

Eligibility

Yes No Not Sure

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
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