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

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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.

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:

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.
We found this trial at
1
site
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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