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

NCT ID: NCT02996721

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 634 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2025-09-04

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.

Conditions

Death; Myocardial Infarction; Cerebral Vascular Accident; Heart Failure Hospitalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Patients randomized to the standard of care 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 at baseline and at study conclusion. No other contact is planned with the standard of care patients. Follow-up will be done by the querying of electronic records, which includes any 25\[OH\] Vit D testing, use of vitamin D supplementation, and outcomes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: BIOLOGICAL

Vitamin D3 (cholecalciferol) will be provided to participants of the study.

Interventions

Vitamin D3

Vitamin D3 (cholecalciferol) will be provided to participants of the study.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi T May, PhD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Intermountain Heart Institute

Joseph B Muhlestein, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Heart Institute

Locations

Intermountain Medical Center

Murray, Utah, United States

Countries

United States

Other Identifiers

1050296

Identifier Type: -

Identifier Source: org_study_id