<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/NCT03258086</url>
  </required_header>
  <id_info>
    <org_study_id>17100043</org_study_id>
    <nct_id>NCT03258086</nct_id>
  </id_info>
  <brief_title>Vitamin D in Diabetic Children</brief_title>
  <official_title>Assessment of Vitamin D in Children With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D is so-called &quot;sunshine vitamin&quot;,it is synthesized in the skin during exposure to&#xD;
      the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure&#xD;
      between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back,&#xD;
      or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also&#xD;
      found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.&#xD;
&#xD;
      Vitamin D supplement is recommended in all infants until enough formula, milk, or other food&#xD;
      sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type&#xD;
      1 diabetes is an autoimmune disease, and the self immune system plays a central role in the&#xD;
      destruction of the beta cell of pancrease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of vitamin D level (ng/ml)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Blood sample</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2ml blood sample of of blood will be taken for assessment of vitamin D</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood sample test</intervention_name>
    <description>blood sample will be taken from all diabetic children for assessment of vitamin D level</description>
    <arm_group_label>Blood sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age (5 years - 15 years ).&#xD;
&#xD;
          -  Type 1 diabetes patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged more than 15 years, less than 2 years.&#xD;
&#xD;
          -  Type 2 diabetes.&#xD;
&#xD;
          -  Neonatal diabetes.&#xD;
&#xD;
          -  Patients with any complications from diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258086
org study id: 17100043
nct id: NCT03258086
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to
      the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure
      between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back,
      or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also
      found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.

      Vitamin D supplement is recommended in all infants until enough formula, milk, or other food
      sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type
      1 diabetes is an autoimmune disease, and the self immune system plays a central role in the
      destruction of the beta cell of pancrease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assessment of vitamin D level (ng/ml)
time frame: 24 hours
arm group label: Blood sample
arm group type: Experimental
description: 2ml blood sample of of blood will be taken for assessment of vitamin D
intervention type: Diagnostic Test
intervention name: blood sample test
description: blood sample will be taken from all diabetic children for assessment of vitamin D level
arm group label: Blood sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Lecturer
mesh term: Vitamin D Deficiency
sharing ipd: Undecided