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

NCT02996721 | Completed Phase 4 FDA Drug

• 1 other identifier: 1050296
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Treatment

EXPERIMENTAL

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.

Biological: Vitamin D3

Interventions

Vitamin D3 BIOLOGICAL

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Death; Myocardial Infarction; Stroke

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Heidi T May, PhD, MSPH

  Intermountain Heart Institute

  PRINCIPAL INVESTIGATOR

• Joseph B Muhlestein, MD

  Intermountain Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: April 3, 2017
• Primary Completion: March 30, 2025
• Study Completion: September 4, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)