<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/NCT03012555</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 13-1056</org_study_id>
    <nct_id>NCT03012555</nct_id>
  </id_info>
  <brief_title>Vitamin D3 in Patients With Sickle Cell Disease</brief_title>
  <official_title>Nutritional Vitamin D3 in Patients With Sickle Cell Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are approximately 90,000 individuals in the United States with sickle cell disease&#xD;
      (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a&#xD;
      vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to&#xD;
      20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic&#xD;
      inflammation and related pain. This study will be coordinated with patients' regularly&#xD;
      scheduled visits for medical care and will require patients to submit blood sample at the&#xD;
      start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a&#xD;
      bone density measurement (DXA scan) at the start of the study and after 12 months of&#xD;
      supplementation to assess for any bone re-mineralization. Thus, the main purpose of this&#xD;
      study is to find the amount of nutritional vitamin D that needs to be taken by patients with&#xD;
      sickle cell disease in order to correct vitamin D deficiency. The study will also test&#xD;
      whether vitamin D supplements improve bone health and reduce inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational cohort study to follow vitamin D levels over time in patients with&#xD;
      sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D&#xD;
      deficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 11, 2016</completion_date>
  <primary_completion_date type="Actual">August 11, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>25(OH)D level</measure>
    <time_frame>12 months</time_frame>
    <description>Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dexa Scan</measure>
    <time_frame>12-18 months</time_frame>
    <description>Change in bone remineralization after 12 months of vitamin D supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP level</measure>
    <time_frame>12 months</time_frame>
    <description>Medical record abstraction for CRP levels to indicate changes in inflammation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Sickle Cell Disease and Vitamin D deficiency</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patients (18 years and older) with a diagnosis of sickle cell disease by hemoglobin&#xD;
        electrophoresis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18 years and older)&#xD;
&#xD;
          -  Diagnosis of sickle cell disease by hemoglobin electrophoresis (HbSS, hematopoietic&#xD;
             blood stem cell [HbSC], Sickle cell b0 Thalassemia, Sickle cell b+ Thalassemia)&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Any race/ethnicity/socioeconomic status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patient (less than 18 years of age)&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX)&#xD;
&#xD;
          -  hypercalcemia (serum calcium level &gt; 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F)&#xD;
&#xD;
          -  Pregnancy: a urine pregnancy test, or a serum pregnancy test, will be obtained at the&#xD;
             time of enrollment in addition to reviewing the medical record; pregnant patients will&#xD;
             be excluded because they should not undergo DXA scanning&#xD;
&#xD;
          -  Patients taking atorvastatin, thiazide diuretics and digoxin, which are medications&#xD;
             that can interact with vitamin D&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jena Simon, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sickle Cell Disease</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT03012555
org study id: GCO 13-1056
nct id: NCT03012555
lead sponsor: 
has dmc: Yes
There are approximately 90,000 individuals in the United States with sickle cell disease
      (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a
      vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to
      20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic
      inflammation and related pain. This study will be coordinated with patients' regularly
      scheduled visits for medical care and will require patients to submit blood sample at the
      start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a
      bone density measurement (DXA scan) at the start of the study and after 12 months of
      supplementation to assess for any bone re-mineralization. Thus, the main purpose of this
      study is to find the amount of nutritional vitamin D that needs to be taken by patients with
      sickle cell disease in order to correct vitamin D deficiency. The study will also test
      whether vitamin D supplements improve bone health and reduce inflammation.
This is an observational cohort study to follow vitamin D levels over time in patients with
      sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D
      deficiency.
observational model: Cohort
time perspective: Prospective
measure: 25(OH)D level
time frame: 12 months
description: Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease
measure: Dexa Scan
time frame: 12-18 months
description: Change in bone remineralization after 12 months of vitamin D supplementation
measure: CRP level
time frame: 12 months
description: Medical record abstraction for CRP levels to indicate changes in inflammation
arm group label: Sickle Cell Disease and Vitamin D deficiency
Whole blood and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jena Simon, MS
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell