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

Phase 4

Active, not recruiting

• Conditions: Heart Failure Hospitalization; Death; Myocardial Infarction; Cerebral Vascular Accident
• Interventions: Biological: Vitamin D3

• Registration Number: NCT02996721
• Lead Sponsor: Intermountain Health Care, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-19
• Study Start: 2017-04-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 890

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Vitamin D3	Patients randomized to the treatment arm will have a 25\[OH\] Vit D test performed, a sample taken and stored for future tests, and completion of a PHQ-9 depression survey. If at baseline a patient has a 25\[OH\] Vit D \>40 ng/mL then follow-up testing will occur 1 year from baseline and the patient will continue current treatment strategy (no supplementation or current supplementation dosage). If baseline 25\[OH\] Vit D levels are \<40 ng/mL then the patient will initiate or increase dose and return in 3 months (±15 days) to determine 25\[OH\] Vit D level. At 3 months, if 25\[OH\] Vit D \>40 ng/mL then current dose should be kept and the patient will return in 1 year for follow-up testing. However, if 25\[OH\] Vit D \<40 ng/mL then patients should double current dose and test again in 3 months. This should occur until 25\[OH\] Vit D reaches a level \>40 ng/mL and once achieved, the patient will return in 1 year for follow-up 25\[OH\] Vit D testing.

Primary Outcome Measures

Name	Time	Method
Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident	from date of randomization until the date of first documented event, up to 48 months

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States