CompletedPhase 4

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

United States634 participantsStarted 2017-04-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident

Timeframe: from date of randomization until the date of first documented event, up to 48 months

Trial details

NCT IDNCT02996721

SponsorIntermountain Health Care, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

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