<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/NCT04450199</url>
  </required_header>
  <id_info>
    <org_study_id>2019-126</org_study_id>
    <nct_id>NCT04450199</nct_id>
  </id_info>
  <brief_title>Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?</brief_title>
  <official_title>Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Podiatry Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess if vitamin D status in the elective foot and ankle fusion population affects fusion&#xD;
      healing categorically (fused vs. un-fused).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level&#xD;
      I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or&#xD;
      midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient&#xD;
      (&lt;30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation&#xD;
      (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be&#xD;
      drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this&#xD;
      study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.&#xD;
&#xD;
      The study will be conducted at 4 investigative sites within the Allegheny Health Network;&#xD;
      West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics &amp;&#xD;
      Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects&#xD;
      are entering the follow-up phase of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The specific aim of this study is to assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing rates. With this information the investigators hope to ascertain if vitamin D supplementation in the perioperative period leads to superior fusion rates than does no supplementation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patients will be blinded for the duration of the study. This will be accomplished by providing the patients with over encapsulated vitamin D and placebo in pill bottles. Twelve (12) over encapsulated 50,000 IU vitamin D2 or placebo tablets will be packaged in pill bottles for patient use. The Foot &amp; Ankle Institute CRC will document which drug the patients received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Union</measure>
    <time_frame>9 months</time_frame>
    <description>Arthrodesis Union using radiographic union determined by independent reviewers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes SF-36 Questionnaire</measure>
    <time_frame>9 months</time_frame>
    <description>Change in patient reported SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes VAS Survey Scores</measure>
    <time_frame>9 months</time_frame>
    <description>Change in patient reported VAS survey scores. The scale shows a series of faces ranging from a happy face at 0, or &quot;no hurt&quot;, to a crying face at 10, which represents &quot;hurts like the worst pain imaginable&quot;. ... The fifth face represents a pain score of 8, and indicates &quot;hurts a whole lot&quot;; the sixth face represents a pain score of 10, and indicates &quot;hurts worst.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 over encapsulated 50,000 IU Vitamin D2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 over encapsulated placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D2</intervention_name>
    <description>Vitamin D tablets</description>
    <arm_group_label>Vitamin D</arm_group_label>
    <other_name>Vitamin D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Over encapsulated sugar pills</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis&#xD;
             surgery&#xD;
&#xD;
          2. Vitamin D serum level &lt;30 ng/mL including those concurrently taking vitamin D&#xD;
&#xD;
          3. Ambulatory&#xD;
&#xD;
          4. Women 18 years of age must have a negative urine/serum pregnancy test and must use an&#xD;
             acceptable method of contraception, including abstinence, a barrier method (diaphragm&#xD;
             or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Revision surgery&#xD;
&#xD;
          2. Tobacco use which has been shown to affect bone healing and increase risk of nonunion&#xD;
&#xD;
          3. Laboratory abnormalities that indicate clinically significant hematologic,&#xD;
             hepatobiliary, or renal disease (EXAMPLE below):&#xD;
&#xD;
             AST/SGOT &gt; 2.0 times the upper limit of normal ALT/SGPT &gt; 2.0 times the upper limit of&#xD;
             normal Total bilirubin &gt; 2.0 times the upper limit of normal Hemoglobin &lt; 9 gm/dL&#xD;
             White blood cell count &lt; 3,000/ mm3 Platelet count &lt; 100,000/mm3 Creatinine &gt; 2.0&#xD;
             times the upper limit of normal&#xD;
&#xD;
          4. Preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus&#xD;
             with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective&#xD;
             tissue disorders, and congenital or acquired disorders of bone metabolism)&#xD;
&#xD;
          5. Preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate&#xD;
             homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D&#xD;
             metabolism, parathyroid disorders, conditions causing abnormal calcium and/or&#xD;
             phosphate absorption)&#xD;
&#xD;
          6. Open wounds to lower extremities which has been shown to increase risk of infection&#xD;
             and nonunion&#xD;
&#xD;
          7. Any investigational drug use within 30 days prior to enrollment.&#xD;
&#xD;
          8. Participation in ongoing clinical research&#xD;
&#xD;
          9. Pregnant or lactating females.&#xD;
&#xD;
         10. Patients who are unable to swallow due to acuity of illness or physiologic reason&#xD;
&#xD;
         11. Patients who are unable to provide consent for the study including inability to read&#xD;
             or speak English&#xD;
&#xD;
         12. Prisoners who are patients because of their vulnerable population and inability to&#xD;
             follow-up&#xD;
&#xD;
         13. Subjects who, in the opinion of the Investigator, may be non-compliant with study&#xD;
             schedules or procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan R Catanzariti, DPM, FACFAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Foot &amp; Ankle Institute, West Penn Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alan R Catanzariti, DPM, FACFAS</last_name>
    <phone>412-688-7575</phone>
    <email>alan.catanzariti@ahn.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kimberly Lockridge</last_name>
    <phone>412-688-7580</phone>
    <email>Kimberly.lockridge2@ahn.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Foot &amp; Ankle Institute/Western Pennsylvania Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan R. Catanzariti, DPM, FACFAS</last_name>
      <phone>412-688-7575</phone>
      <email>alan.catanzariti@ahn.org</email>
    </contact>
    <contact_backup>
      <last_name>Angela Finamore</last_name>
      <phone>412-359-8805</phone>
      <email>Angela.Finamore@ahn.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kimberly Lockridge, DPM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 29, 2022</last_update_submitted>
  <last_update_submitted_qc>July 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</investigator_affiliation>
    <investigator_full_name>Alan Catanzariti</investigator_full_name>
    <investigator_title>Program Director, Foot and Ankle Residency Training Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</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>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This study has plans for publication and presentation to include a specialized peer reviewed international scientific journal and national conference, respectively. The Principal Investigator and Co-Investigator are part of the AHN and will have complete access to all data for the purpose of publication at study completion. Thanks to the generosity of funding from The Podiatry Foundation of Ohio, making this study possible.</ipd_description>
  </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/NCT04450199
org study id: 2019-126
nct id: NCT04450199
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To assess if vitamin D status in the elective foot and ankle fusion population affects fusion
      healing categorically (fused vs. un-fused).
This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level
      I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or
      midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient
      (<30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation
      (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be
      drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this
      study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.

      The study will be conducted at 4 investigative sites within the Allegheny Health Network;
      West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics &
      Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects
      are entering the follow-up phase of the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The specific aim of this study is to assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing rates. With this information the investigators hope to ascertain if vitamin D supplementation in the perioperative period leads to superior fusion rates than does no supplementation.
primary purpose: Treatment
masking: Single (Participant)
masking description: The patients will be blinded for the duration of the study. This will be accomplished by providing the patients with over encapsulated vitamin D and placebo in pill bottles. Twelve (12) over encapsulated 50,000 IU vitamin D2 or placebo tablets will be packaged in pill bottles for patient use. The Foot & Ankle Institute CRC will document which drug the patients received.
measure: Time to Union
time frame: 9 months
description: Arthrodesis Union using radiographic union determined by independent reviewers
measure: Patient Reported Outcomes SF-36 Questionnaire
time frame: 9 months
description: Change in patient reported SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
measure: Patient Reported Outcomes VAS Survey Scores
time frame: 9 months
description: Change in patient reported VAS survey scores. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". ... The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst."
arm group label: Vitamin D
arm group type: Active Comparator
description: 12 over encapsulated 50,000 IU Vitamin D2
arm group label: Placebo
arm group type: Placebo Comparator
description: 12 over encapsulated placebo tablets
intervention type: Drug
intervention name: Vitamin D2
description: Vitamin D tablets
arm group label: Vitamin D
other name: Vitamin D
intervention type: Other
intervention name: Placebo
description: Over encapsulated sugar pills
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Alan R Catanzariti, DPM, FACFAS
role: Principal Investigator
affiliation: The Foot & Ankle Institute, West Penn Hospital
last name: Alan R Catanzariti, DPM, FACFAS
phone: 412-688-7575
email: alan.catanzariti@ahn.org
last name: Kimberly Lockridge
phone: 412-688-7580
email: Kimberly.lockridge2@ahn.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
investigator full name: Alan Catanzariti
investigator title: Program Director, Foot and Ankle Residency Training Program
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No
ipd description: This study has plans for publication and presentation to include a specialized peer reviewed international scientific journal and national conference, respectively. The Principal Investigator and Co-Investigator are part of the AHN and will have complete access to all data for the purpose of publication at study completion. Thanks to the generosity of funding from The Podiatry Foundation of Ohio, making this study possible.