<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996721</url>
  </required_header>
  <id_info>
    <org_study_id>1050296</org_study_id>
    <nct_id>NCT02996721</nct_id>
  </id_info>
  <brief_title>A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients</brief_title>
  <acronym>TARGET-D</acronym>
  <official_title>A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (&gt;40 ng/mL)&#xD;
      among myocardial infarction patients will result in a reduction of cardiovascular-related&#xD;
      adverse events. Half of the patients will be randomized to receive standard of care and half&#xD;
      will receive clinical management of 25[OH] Vit D levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low 25[OH] Vit D levels have become a public epidemic with increasing recognition of its&#xD;
      widespread insufficiency both in the United States and worldwide. Epidemiologic studies have&#xD;
      associated low 25[OH] Vit D levels with coronary risk factors and adverse cardiovascular&#xD;
      outcomes. However, randomized trials are needed to establish the relevance of 25[OH] Vit D&#xD;
      status to cardiovascular health. While a few randomized trials have evaluated vitamin D&#xD;
      supplementation, none have &quot;treated to target&quot; (i.e., individual dosing so that adequate&#xD;
      25[OH] Vit D levels are obtained), but have rather given &quot;blanket&quot; doses regardless of 25[OH]&#xD;
      Vit D level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident</measure>
    <time_frame>from date of randomization until the date of first documented event, up to 48 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">890</enrollment>
  <condition>Death</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Cerebral Vascular Accident</condition>
  <condition>Heart Failure Hospitalization</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &gt;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 &lt;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 &gt;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 &lt;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 &gt;40 ng/mL and once achieved, the patient will return in 1 year for follow-up 25[OH] Vit D testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Vitamin D3 (cholecalciferol) will be provided to participants of the study.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients, both male and female, &gt;18 years old&#xD;
&#xD;
          2. Undergone angiography for a MI (troponin positive [&gt;0.04 ng/mL] and ACS diagnosis)&#xD;
             within the past month&#xD;
&#xD;
          3. Receive follow-up care at an Intermountain Healthcare facility&#xD;
&#xD;
          4. Not taking or taking &lt;1000 IU of vitamin D daily within the last 3 months&#xD;
&#xD;
          5. Willing to provide informed consent and participate in follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to vitamin D products&#xD;
&#xD;
          2. History of previous vitamin D supplementation of &gt;1000 IU daily within the past 3&#xD;
             months (i.e., &gt;40% of the days during the past 3 months).&#xD;
&#xD;
          3. Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a&#xD;
             reduced (&lt;12 months) life expectancy&#xD;
&#xD;
          4. Hypercalcemia (calcium levels &gt;10.6 mg/dL)&#xD;
&#xD;
          5. Subject participation in previous investigational interventional studies within 30&#xD;
             days of the current study.&#xD;
&#xD;
          6. History of psychiatric illness/condition that would interfere with their ability to&#xD;
             understand or complete the requirements of the study, a condition that in the opinion&#xD;
             of the investigator or their designee places the subject at an unacceptable risk as a&#xD;
             participant.&#xD;
&#xD;
          7. Pregnant and/or lactating women and women of child bearing potential who are not using&#xD;
             acceptable means of contraception as determined by the clinical investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi T May, PhD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joseph B Muhlestein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Heart Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heidi T May, PhD, MSPH</last_name>
    <phone>801-507-4822</phone>
    <email>heidi.may@imail.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patti Spencer</last_name>
    <phone>801-507-4709</phone>
    <email>patti.spencer@imail.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heidi T May, PhD, MPH</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996721
org study id: 1050296
nct id: NCT02996721
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
arm group label: Standard of Care
arm group type: No Intervention
description: 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.
arm group label: Treatment
arm group type: Experimental
description: 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.
intervention type: Biological
intervention name: Vitamin D3
description: Vitamin D3 (cholecalciferol) will be provided to participants of the study.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heidi T May, PhD, MSPH
role: Principal Investigator
affiliation: Intermountain Heart Institute
last name: Joseph B Muhlestein, MD
role: Principal Investigator
affiliation: Intermountain Heart Institute
last name: Heidi T May, PhD, MSPH
phone: 801-507-4822
email: heidi.may@imail.org
last name: Patti Spencer
phone: 801-507-4709
email: patti.spencer@imail.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No