A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Cardiology, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/13/2018 |
Start Date: | April 3, 2017 |
End Date: | April 2021 |
Contact: | Heidi T May, PhD, MSPH |
Email: | heidi.may@imail.org |
Phone: | 801-507-4822 |
A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)
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.
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.
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.
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:
1. Patients, both male and female, >18 years old
2. Undergone angiography for a MI (troponin positive [>0.04 ng/mL] and ACS diagnosis)
within the past month
3. Receive follow-up care at an Intermountain Healthcare facility
4. Not taking or taking <1000 IU of vitamin D daily within the last 3 months
5. Willing to provide informed consent and participate in follow-up visits
Exclusion Criteria:
1. Hypersensitivity to vitamin D products
2. 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).
3. Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a
reduced (<12 months) life expectancy
4. Hypercalcemia (calcium levels >10.6 mg/dL)
5. Subject participation in previous investigational interventional studies within 30
days of the current study.
6. 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.
7. 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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