<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/NCT02208310</url>
  </required_header>
  <id_info>
    <org_study_id>CCFA-329225</org_study_id>
    <nct_id>NCT02208310</nct_id>
  </id_info>
  <brief_title>Trial of High Dose Vitamin D in Patient's With Crohn's Disease</brief_title>
  <acronym>RODIN-CD</acronym>
  <official_title>A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Crohn's and Colitis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is&#xD;
      a major source of vitamin D. There is some research to suggest that patient's with higher&#xD;
      vitamin D levels are less likely to undergo surgeries and have better control of their&#xD;
      disease. We intend to study the effects of high dose vitamin D supplementation in patients&#xD;
      with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses&#xD;
      will have less hospitalizations, surgeries, steroid use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are randomized to low or high dose vitamin D, and outcomes including steroid&#xD;
      prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified&#xD;
      Harvey-Bradshaw Index are measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions</measure>
    <time_frame>Day 180</time_frame>
    <description>Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypercalcemia</measure>
    <time_frame>Day 180</time_frame>
    <description>Hypercalcemia is presented as number of participants with Calcium &gt;10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Nephrolithiasis</measure>
    <time_frame>Day 180</time_frame>
    <description>Incidence of nephrolithiasis associated with hypercalcemia (&gt;10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crohn's Related Hospitalizations</measure>
    <time_frame>Day 180</time_frame>
    <description>Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steroid Prescription Given (Dichotomous 0/1)</measure>
    <time_frame>Day 180</time_frame>
    <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)</measure>
    <time_frame>Day 180</time_frame>
    <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Harvey-Bradshaw Index (HBI Without Examination)</measure>
    <time_frame>Day 180</time_frame>
    <description>modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive Protein</measure>
    <time_frame>Day 180</time_frame>
    <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Fecal Calprotectin</measure>
    <time_frame>1 year</time_frame>
    <description>Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent With Escalation of Therapy</measure>
    <time_frame>Day 180</time_frame>
    <description>Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measure Changes</measure>
    <time_frame>Day 180</time_frame>
    <description>change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).&#xD;
Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue Measurements</measure>
    <time_frame>Day 180</time_frame>
    <description>Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With at Least One Crohn's Related Emergency Department (ED) Visit</measure>
    <time_frame>Day 180</time_frame>
    <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Low Dose Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. &lt;-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. &lt;-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol 10,000 IU</intervention_name>
    <description>Cholecalciferol 10,000 IU po daily</description>
    <arm_group_label>High Dose Vitamin D</arm_group_label>
    <other_name>High Dose Vitamin D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol 400 IU</intervention_name>
    <description>Cholecalciferol 400 IU po daily</description>
    <arm_group_label>Low Dose Vitamin D</arm_group_label>
    <other_name>Low dose vitamin D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CD&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;75&#xD;
&#xD;
          -  Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D &lt; 30ng/ml)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corticosteroid use in the last 4 weeks&#xD;
&#xD;
          -  CD-related surgery in the last 6 months&#xD;
&#xD;
          -  CD-related hospitalization in the last 4 weeks&#xD;
&#xD;
          -  Pregnancy, intended pregnancy during the study period or nursing&#xD;
&#xD;
          -  Serum calcium &gt;10.2 mg/dL&#xD;
&#xD;
          -  History of primary sclerosing cholangitis&#xD;
&#xD;
          -  History of undergoing an ileal pouch-anal anastomosis&#xD;
&#xD;
          -  Current active perianal disease&#xD;
&#xD;
          -  History of nephrolithiasis in the past 2 years&#xD;
&#xD;
          -  Anticipated change in therapy in the next 30 days (steroids, biologic initiation)&#xD;
&#xD;
          -  modified Harvey-Bradshaw Index of 10 or more&#xD;
&#xD;
          -  History of decreased renal function (glomerular filtration rate &lt;30ml/min based on&#xD;
             MDRD) or polycystic kidney disease&#xD;
&#xD;
          -  History of sarcoidosis&#xD;
&#xD;
          -  History of hyperparathyroidism&#xD;
&#xD;
          -  Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma&#xD;
&#xD;
          -  Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or&#xD;
             primidone&#xD;
&#xD;
          -  Osteoporosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter D. Higgins, MD, PhD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shail M Govani, M.D., M.Sc.</last_name>
    <role>Study Director</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans Herfarth, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>55240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jorgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, Bartels LE, Kelsen J, Christensen LA, Dahlerup JF. Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study. Aliment Pharmacol Ther. 2010 Aug;32(3):377-83. doi: 10.1111/j.1365-2036.2010.04355.x. Epub 2010 May 11.</citation>
    <PMID>20491740</PMID>
  </reference>
  <reference>
    <citation>Khalili H, Huang ES, Ananthakrishnan AN, Higuchi L, Richter JM, Fuchs CS, Chan AT. Geographical variation and incidence of inflammatory bowel disease among US women. Gut. 2012 Dec;61(12):1686-92. doi: 10.1136/gutjnl-2011-301574. Epub 2012 Jan 11.</citation>
    <PMID>22241842</PMID>
  </reference>
  <reference>
    <citation>Cantorna MT, Munsick C, Bemiss C, Mahon BD. 1,25-Dihydroxycholecalciferol prevents and ameliorates symptoms of experimental murine inflammatory bowel disease. J Nutr. 2000 Nov;130(11):2648-52. doi: 10.1093/jn/130.11.2648.</citation>
    <PMID>11053501</PMID>
  </reference>
  <reference>
    <citation>Ananthakrishnan AN, Khalili H, Higuchi LM, Bao Y, Korzenik JR, Giovannucci EL, Richter JM, Fuchs CS, Chan AT. Higher predicted vitamin D status is associated with reduced risk of Crohn's disease. Gastroenterology. 2012 Mar;142(3):482-9. doi: 10.1053/j.gastro.2011.11.040. Epub 2011 Dec 9.</citation>
    <PMID>22155183</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>March 19, 2017</results_first_submitted>
  <results_first_submitted_qc>August 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2017</results_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Peter Higgins</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>Vitamin D deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low Dose Vitamin D</title>
          <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
        </group>
        <group group_id="P2">
          <title>High Dose Vitamin D</title>
          <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Day 180</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low Dose Vitamin D</title>
          <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
        </group>
        <group group_id="B2">
          <title>High Dose Vitamin D</title>
          <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.2" spread="14.2"/>
                    <measurement group_id="B2" value="35.2" spread="9.0"/>
                    <measurement group_id="B3" value="34.6" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions</title>
        <description>Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions</title>
          <description>Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hypercalcemia</title>
        <description>Hypercalcemia is presented as number of participants with Calcium &gt;10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Hypercalcemia</title>
          <description>Hypercalcemia is presented as number of participants with Calcium &gt;10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Nephrolithiasis</title>
        <description>Incidence of nephrolithiasis associated with hypercalcemia (&gt;10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Nephrolithiasis</title>
          <description>Incidence of nephrolithiasis associated with hypercalcemia (&gt;10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Crohn's Related Hospitalizations</title>
        <description>Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Crohn's Related Hospitalizations</title>
          <description>Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>CD-related hospitalization occurred</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steroid Prescription Given (Dichotomous 0/1)</title>
        <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Steroid Prescription Given (Dichotomous 0/1)</title>
          <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred</description>
          <units>Steroid prescription occurred</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)</title>
        <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)</title>
          <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject</description>
          <units>CD-related surgery occurred</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Modified Harvey-Bradshaw Index (HBI Without Examination)</title>
        <description>modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Modified Harvey-Bradshaw Index (HBI Without Examination)</title>
          <description>modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI.</description>
          <units>units on a scale (0-16)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in C-reactive Protein</title>
        <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Change in C-reactive Protein</title>
          <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.</description>
          <units>mg/dL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Fecal Calprotectin</title>
        <description>Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.</description>
        <time_frame>1 year</time_frame>
        <population>Results were not collected on any subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Fecal Calprotectin</title>
          <description>Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.</description>
          <population>Results were not collected on any subjects</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent With Escalation of Therapy</title>
        <description>Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Percent With Escalation of Therapy</title>
          <description>Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Measure Changes</title>
        <description>change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).&#xD;
Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Measure Changes</title>
          <description>change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).&#xD;
Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fatigue Measurements</title>
        <description>Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fatigue Measurements</title>
          <description>Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.&#xD;
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With at Least One Crohn's Related Emergency Department (ED) Visit</title>
        <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject</description>
        <time_frame>Day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vitamin D</title>
            <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
          </group>
          <group group_id="O2">
            <title>High Dose Vitamin D</title>
            <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With at Least One Crohn's Related Emergency Department (ED) Visit</title>
          <description>Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs are reported for as long as participants remained in the study. All but one had left short of 6 months; one continued through the 6 month milestone.</time_frame>
      <desc>Not different</desc>
      <group_list>
        <group group_id="E1">
          <title>Low Dose Vitamin D</title>
          <description>Patients will be given 400 IU cholecalciferol once daily for 30 days. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.&#xD;
Cholecalciferol 400 IU</description>
        </group>
        <group group_id="E2">
          <title>High Dose Vitamin D</title>
          <description>Patients will be given cholecalciferol 10,000 IU daily for 30 days. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if &lt;50 ng/ml, a 30 day course will be administered.&#xD;
Cholecalciferol 10,000 IU</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>SNOMED CT</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <description>Urinary Tract Infection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Very few patients with inactive disease had low vitamin D levels, so most patients screened were ineligible. This made recruitment very slow, and the project was terminated.Suggests low vitamin D could be a marker of activity, rather than a cause</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Peter Higgins</name_or_title>
      <organization>University of Michigan</organization>
      <phone>7346472964</phone>
      <email>phiggins@umich.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02208310
org study id: CCFA-329225
nct id: NCT02208310
lead sponsor: 
collaborator: 
has dmc: No
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is
      a major source of vitamin D. There is some research to suggest that patient's with higher
      vitamin D levels are less likely to undergo surgeries and have better control of their
      disease. We intend to study the effects of high dose vitamin D supplementation in patients
      with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses
      will have less hospitalizations, surgeries, steroid use.
Subjects are randomized to low or high dose vitamin D, and outcomes including steroid
      prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified
      Harvey-Bradshaw Index are measured.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
time frame: Day 180
description: Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Hypercalcemia
time frame: Day 180
description: Hypercalcemia is presented as number of participants with Calcium >10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Incidence of Nephrolithiasis
time frame: Day 180
description: Incidence of nephrolithiasis associated with hypercalcemia (>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Crohn's Related Hospitalizations
time frame: Day 180
description: Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Steroid Prescription Given (Dichotomous 0/1)
time frame: Day 180
description: Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred
measure: Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)
time frame: Day 180
description: Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject
measure: Change in Modified Harvey-Bradshaw Index (HBI Without Examination)
time frame: Day 180
description: modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI.
measure: Change in C-reactive Protein
time frame: Day 180
description: Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.
measure: Changes in Fecal Calprotectin
time frame: 1 year
description: Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.
measure: Percent With Escalation of Therapy
time frame: Day 180
description: Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Quality of Life Measure Changes
time frame: Day 180
description: change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).
Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Change in Fatigue Measurements
time frame: Day 180
description: Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.
Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
measure: Participants With at Least One Crohn's Related Emergency Department (ED) Visit
time frame: Day 180
description: Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject
arm group label: Low Dose Vitamin D
arm group type: Active Comparator
description: Patients will be given 400 IU cholecalciferol once daily for 30 days. <-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March.
arm group label: High Dose Vitamin D
arm group type: Experimental
description: Patients will be given cholecalciferol 10,000 IU daily for 30 days. <-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if <50 ng/ml, a 30 day course will be administered.
intervention type: Drug
intervention name: Cholecalciferol 10,000 IU
description: Cholecalciferol 10,000 IU po daily
arm group label: High Dose Vitamin D
other name: High Dose Vitamin D
intervention type: Drug
intervention name: Cholecalciferol 400 IU
description: Cholecalciferol 400 IU po daily
arm group label: Low Dose Vitamin D
other name: Low dose vitamin D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Peter D. Higgins, MD, PhD, MSc
role: Principal Investigator
affiliation: University of Michigan
last name: Shail M Govani, M.D., M.Sc.
role: Study Director
affiliation: University of Michigan
last name: Hans Herfarth, MD, PhD
role: Study Director
affiliation: University of North Carolina
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Jorgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, Bartels LE, Kelsen J, Christensen LA, Dahlerup JF. Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study. Aliment Pharmacol Ther. 2010 Aug;32(3):377-83. doi: 10.1111/j.1365-2036.2010.04355.x. Epub 2010 May 11.
PMID: 20491740
citation: Khalili H, Huang ES, Ananthakrishnan AN, Higuchi L, Richter JM, Fuchs CS, Chan AT. Geographical variation and incidence of inflammatory bowel disease among US women. Gut. 2012 Dec;61(12):1686-92. doi: 10.1136/gutjnl-2011-301574. Epub 2012 Jan 11.
PMID: 22241842
citation: Cantorna MT, Munsick C, Bemiss C, Mahon BD. 1,25-Dihydroxycholecalciferol prevents and ameliorates symptoms of experimental murine inflammatory bowel disease. J Nutr. 2000 Nov;130(11):2648-52. doi: 10.1093/jn/130.11.2648.
PMID: 11053501
citation: Ananthakrishnan AN, Khalili H, Higuchi LM, Bao Y, Korzenik JR, Giovannucci EL, Richter JM, Fuchs CS, Chan AT. Higher predicted vitamin D status is associated with reduced risk of Crohn's disease. Gastroenterology. 2012 Mar;142(3):482-9. doi: 10.1053/j.gastro.2011.11.040. Epub 2011 Dec 9.
PMID: 22155183
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Peter Higgins
investigator title: Assistant Professor
mesh term: Crohn Disease
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Very few patients with inactive disease had low vitamin D levels, so most patients screened were ineligible. This made recruitment very slow, and the project was terminated.Suggests low vitamin D could be a marker of activity, rather than a cause
point of contact: 