A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among M… (NCT02996721) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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.