<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/NCT01697228</url>
  </required_header>
  <id_info>
    <org_study_id>11-00352</org_study_id>
    <nct_id>NCT01697228</nct_id>
  </id_info>
  <brief_title>The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM</brief_title>
  <official_title>The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a prospective cross-over study to evaluate the effects of&#xD;
      vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in&#xD;
      microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to&#xD;
      see a significant improvement in glycemic control and a reduction of serum pro-inflammatory&#xD;
      markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who&#xD;
      are treated with vitamin D.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pro-inflammatory markers</measure>
    <time_frame>6 months</time_frame>
    <description>Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D level and proinflammatory markers</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D levels on insulin requirements</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation between the change of vitamin D levels on insulin requirements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D level and HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation between the change in vitamin D level in the blood and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline differences between vitamin D deficient &amp; sufficient subjects</measure>
    <time_frame>Baseline</time_frame>
    <description>Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Vitamin D Deficiency/Insufficiency</condition>
  <arm_group>
    <arm_group_label>Immediate treatment group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed treatment group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <arm_group_label>Delayed treatment group</arm_group_label>
    <arm_group_label>Immediate treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males&#xD;
             or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion&#xD;
             criteria for sexual maturity are met, a physical exam for research purposes will be&#xD;
             performed.&#xD;
&#xD;
          2. HbA1c between 7 to 9%&#xD;
&#xD;
          3. Adequate renal function (serum creatinine &lt; 1.5 mg/dL in males and &lt; 1.2 mg/dL in&#xD;
             females) and adequate liver function (AST and ALT &lt; 2.5 times the upper limit of&#xD;
             normal)&#xD;
&#xD;
          4. Vitamin D insufficiency or deficiency (25-OH vit D level &lt; 30ng/mL) which will be&#xD;
             determined on initial screening labs after consenting subjects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Less than 13 or greater than 21 years of age&#xD;
&#xD;
          2. Less than Tanner stage 4 sexual maturity for males or pre-menarche&#xD;
&#xD;
          3. HbA1c less than 7% or greater than 9%&#xD;
&#xD;
          4. T1DM for less than 1 year&#xD;
&#xD;
          5. Vitamin D sufficient (25-OH vit D level &gt; 30 ng/mL)&#xD;
&#xD;
          6. Currently taking any medication that can interfere with vitamin D synthesis or&#xD;
             metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin,&#xD;
             Anti-tuberculosis drugs&#xD;
&#xD;
          7. Currently taking any medication other than insulin that alters blood glucose levels,&#xD;
             including but not limited to systemic glucocorticoids&#xD;
&#xD;
          8. Inadequate renal function (serum creatinine &gt; 1.5mg/dL in males and &gt; 1.2mg/dL in&#xD;
             females) or inadequate liver function (AST and ALT &gt; 2.5 times the upper limit of&#xD;
             normal)&#xD;
&#xD;
          9. Evidence of malabsorption or short gut.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roshanak Monzavi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>Roshanak Monzavi MD</investigator_full_name>
    <investigator_title>Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Proinflammatory markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</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>
  </intervention_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/NCT01697228
org study id: 11-00352
nct id: NCT01697228
lead sponsor: 
has dmc: Yes
The investigators are conducting a prospective cross-over study to evaluate the effects of
      vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in
      microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to
      see a significant improvement in glycemic control and a reduction of serum pro-inflammatory
      markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who
      are treated with vitamin D.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hemoglobin A1c
time frame: 6 months
description: The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)
measure: Pro-inflammatory markers
time frame: 6 months
description: Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods
measure: Vitamin D level and proinflammatory markers
time frame: 6 months
description: Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α
measure: Vitamin D levels on insulin requirements
time frame: 6 months
description: Correlation between the change of vitamin D levels on insulin requirements
measure: Vitamin D level and HbA1c
time frame: 6 months
description: Correlation between the change in vitamin D level in the blood and change in HbA1c
measure: Baseline differences between vitamin D deficient & sufficient subjects
time frame: Baseline
description: Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements
arm group label: Immediate treatment group
arm group type: Other
description: This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.
arm group label: Delayed treatment group
arm group type: Other
description: This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.
intervention type: Dietary Supplement
intervention name: Vitamin D
arm group label: Delayed treatment group
arm group label: Immediate treatment group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 21 Years
healthy volunteers: No
last name: Roshanak Monzavi, M.D.
role: Principal Investigator
affiliation: Children's Hospital Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: Roshanak Monzavi MD
investigator title: Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism
mesh term: Diabetes Mellitus, Type 1
mesh term: Vitamin D Deficiency
mesh term: Vitamin D