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

Myocardial Infarction Clinical Trial

— TARGET-D  

Official title:

A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02996721
• Other study ID #: 1050296
• Status: Recruiting
• Phase: Phase 4
• Start date: April 3, 2017
• Est. completion date: April 2023

Study information

• Verified date: August 2022
• Source: Intermountain Health Care, Inc.
• Contact: Heidi T May, PhD, MSPH
• Phone: 801-507-4822
• Email: heidi.may[@]imail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 890
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Death
• Heart Failure Hospitalization
• Infarction
• Myocardial Infarction
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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