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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Death Myocardial Infarction Cerebral Vascular Accident Heart Failure Hospitalization Biological: Vitamin D3 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Experimental: 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.
Biological: Vitamin D3
Vitamin D3 (cholecalciferol) will be provided to participants of the study.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Heidi T May, PhD, MSPH 801-507-4822 heidi.may@imail.org
Contact: Patti Spencer 801-507-4709 patti.spencer@imail.org

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Heidi T May, PhD, MPH         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Heidi T May, PhD, MSPH Intermountain Heart Institute
Principal Investigator: Joseph B Muhlestein, MD Intermountain Heart Institute

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02996721     History of Changes
Other Study ID Numbers: 1050296
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Infarction
Myocardial Infarction
Stroke
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents