A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (TARGET-D)
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|ClinicalTrials.gov Identifier: NCT02996721|
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Death Myocardial Infarction Cerebral Vascular Accident Heart Failure Hospitalization||Biological: Vitamin D3||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||890 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
No Intervention: 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.
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
Vitamin D3 (cholecalciferol) will be provided to participants of the study.
- Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident [ Time Frame: from date of randomization until the date of first documented event, up to 48 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996721
|Contact: Heidi T May, PhD, MSPHfirstname.lastname@example.org|
|Contact: Patti Spenceremail@example.com|
|United States, Utah|
|Intermountain Medical Center||Recruiting|
|Murray, Utah, United States, 84157|
|Contact: Heidi T May, PhD, MPH|
|Principal Investigator:||Heidi T May, PhD, MSPH||Intermountain Heart Institute|
|Principal Investigator:||Joseph B Muhlestein, MD||Intermountain Heart Institute|