<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/NCT03793309</url>
  </required_header>
  <id_info>
    <org_study_id>12012016</org_study_id>
    <nct_id>NCT03793309</nct_id>
  </id_info>
  <brief_title>Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants</brief_title>
  <official_title>A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in&#xD;
      preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives&#xD;
      800 IU vitamin D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent.&#xD;
      Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance&#xD;
      cellular immunity by increasing T regulatory cells is unknown. The effect of two different&#xD;
      doses of vitamin D; 400 IU and 800 IU will be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in The Number of T Regulatory Cells</measure>
    <time_frame>At 1 week (compared to baseline)</time_frame>
    <description>Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in The Number of T Regulatory Cells</measure>
    <time_frame>At 4 weeks (compared to baseline)</time_frame>
    <description>Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Prematurity</condition>
  <condition>Immune Defect</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group receive 400 IU vitamin D daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group receive 800 IU vitamin D daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Oral vitamin D</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
    <other_name>Oral vitamin D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants with gestational age 28-33 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Necrotizing enterocolitis&#xD;
&#xD;
          -  Bowel perforation&#xD;
&#xD;
          -  Chromosomal anomalies&#xD;
&#xD;
          -  Inborn errors of metabolism&#xD;
&#xD;
          -  Major congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lamiaa Mohsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University Children's Hospital</affiliation>
  </overall_official>
  <results_reference>
    <citation>Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.</citation>
    <PMID>28779655</PMID>
  </results_reference>
  <results_reference>
    <citation>Zittermann A, Dembinski J, Stehle P. Low vitamin D status is associated with low cord blood levels of the immunosuppressive cytokine interleukin-10. Pediatr Allergy Immunol. 2004 Jun;15(3):242-6. doi: 10.1111/j.1399-3038.2004.00140.x.</citation>
    <PMID>15209957</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Lamiaa Mohsen</investigator_full_name>
    <investigator_title>professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03793309
org study id: 12012016
nct id: NCT03793309
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in
      preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives
      800 IU vitamin D.
Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent.
      Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance
      cellular immunity by increasing T regulatory cells is unknown. The effect of two different
      doses of vitamin D; 400 IU and 800 IU will be studied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change in The Number of T Regulatory Cells
time frame: At 1 week (compared to baseline)
description: Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells
measure: Percent Change in The Number of T Regulatory Cells
time frame: At 4 weeks (compared to baseline)
description: Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells
arm group label: Low dose
arm group type: Experimental
description: Subjects in this group receive 400 IU vitamin D daily for 4 weeks.
arm group label: High dose
arm group type: Experimental
description: Subjects in this group receive 800 IU vitamin D daily for 4 weeks.
intervention type: Drug
intervention name: Vitamin D
description: Oral vitamin D
arm group label: High dose
arm group label: Low dose
other name: Oral vitamin D
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
last name: Lamiaa Mohsen, MD
role: Principal Investigator
affiliation: Cairo University Children's Hospital
citation: Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.
PMID: 28779655
citation: Zittermann A, Dembinski J, Stehle P. Low vitamin D status is associated with low cord blood levels of the immunosuppressive cytokine interleukin-10. Pediatr Allergy Immunol. 2004 Jun;15(3):242-6. doi: 10.1111/j.1399-3038.2004.00140.x.
PMID: 15209957
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Lamiaa Mohsen
investigator title: professor of Pediatrics
mesh term: Premature Birth
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No