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Evaluating Vitamin D Normalization on Cardiovascular-Related Events

Jun 11, 2019

Overview

 

This study evaluates whether achieving 25-hydroxyvitamin D, or  25[OH] Vit D (what vitamin D is converted into when introduced into the body) levels (>40 ng/mL) among myocardial infarction (bad heart valve circulatory) 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.

 

Study Information

 

This is an interventional, randomized, parallel assignment with an estimated 890 participants. The study began on April 3, 2017 and is estimated to be completed by April 2021.

 

Inclusion Criteria

 

  • All sexes, ages 18 years and older
  • Undergone angiography for a MI, troponin positive, [>0.04 ng/mL] and acute coronary syndrome (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,
  • Pregnant and/or lactating women
  • Women of childbearing potential who are not using acceptable means of contraception

 

Location

 

You may participate in this clinical trial at Intermountain Medical Center in Murray, Utah, United States, 84157. If you have any questions or concerns you may contact Heidi T May, PhD, MPH.

 

Sponsors/Collaborators

 

This study is sponsored by Intermountain Health Care, Inc.with Heidi T May, PhD, MSPH and Joseph B. Muhlestein, MD at the Principal Investigators.

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