<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/NCT03005496</url>
  </required_header>
  <id_info>
    <org_study_id>50/UN.2F1/ETIK/2016</org_study_id>
    <nct_id>NCT03005496</nct_id>
  </id_info>
  <brief_title>The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β</brief_title>
  <official_title>The Effect of Zinc, Beta-carotene, and Vitamin D3 Supplementation as Pro-inflammation Mediated Regulator in Preterm Delivery Through Placental Protein Adaptor MyD88 and TRIF, Transcription Factor NFkB, and Pro-inflammatory Cytokine IL-1β</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a controlled trial which compares the effect of zinc, beta-carotene, and&#xD;
      Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is&#xD;
      zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels&#xD;
      in placenta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.&#xD;
&#xD;
      Each participant of each group will be given the medication of preterm birth hospital&#xD;
      protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg&#xD;
      intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood&#xD;
      sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be&#xD;
      divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene&#xD;
      25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the&#xD;
      intervention. Each participant will be observed until delivery. After delivery, level of&#xD;
      zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of&#xD;
      MyD88, TRIF, NFκB, and IL-1β in placenta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>placenta MyD88</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>placenta TRIF</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placenta NFkB</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placenta 25(OH)D</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placenta vitamin A</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placenta zinc</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placenta IL-1B</measure>
    <time_frame>1 year</time_frame>
    <description>Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum zinc</measure>
    <time_frame>1 year</time_frame>
    <description>Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum 25(OH)D</measure>
    <time_frame>1 year</time_frame>
    <description>Serum 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum vitamin A</measure>
    <time_frame>1 year</time_frame>
    <description>Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>PreTerm Birth</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nifedipin 4x10 mg oral&#xD;
Dexamethasone 2x6 mg iv for 2 days&#xD;
Zinc 50 mg/day&#xD;
Beta-carotene 25,000 IU&#xD;
Vitamin D3 50,000 IU/weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nifedipin 4x10 mg&#xD;
Dexamethasone 2x6 mg iv for 2 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zinc</intervention_name>
    <description>included in intervention arm</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Zinc Picolinate 50 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nifedipine</intervention_name>
    <description>included in intervention and control arm</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Nifedipine 10 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beta Carotene</intervention_name>
    <description>included in intervention arm</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Beta carotene 25,000 IU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>included in intervention arm</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Cholecalciferol 50,000 IU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>included in intervention and control arm</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Dexamethasone 6 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who has preterm birth in 26-36 weeks gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Drug allergy&#xD;
&#xD;
          -  Intra Uterine Growth Retardation (IUGR) is detected&#xD;
&#xD;
          -  Congenital malformation in fetus was found&#xD;
&#xD;
          -  Preterm Premature Rupture of Membrane (PPROM)&#xD;
&#xD;
          -  Maternal complication such as gestational hypertension, preeclampsia, gestational&#xD;
             diabetes mellitus, heart disease, infection, and autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>November 18, 2017</last_update_submitted>
  <last_update_submitted_qc>November 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Rima Irwinda</investigator_full_name>
    <investigator_title>MD</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>Cholecalciferol</mesh_term>
    <mesh_term>Beta Carotene</mesh_term>
    <mesh_term>Zinc</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Nifedipine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
    <mesh_term>Carotenoids</mesh_term>
    <mesh_term>Picolinic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>February 27, 2019</submitted>
    <returned>March 19, 2019</returned>
  </pending_results>
  <!-- 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/NCT03005496
org study id: 50/UN.2F1/ETIK/2016
nct id: NCT03005496
lead sponsor: 
has dmc: Yes
This study is a controlled trial which compares the effect of zinc, beta-carotene, and
      Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is
      zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels
      in placenta.
The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.

      Each participant of each group will be given the medication of preterm birth hospital
      protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg
      intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood
      sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be
      divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene
      25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the
      intervention. Each participant will be observed until delivery. After delivery, level of
      zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of
      MyD88, TRIF, NFκB, and IL-1β in placenta.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: placenta MyD88
time frame: 1 year
description: Placenta MyD88 will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
measure: placenta TRIF
time frame: 1 year
description: Placenta TRIF will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
measure: Placenta NFkB
time frame: 1 year
description: Placenta NFkB will be measured by immunochemistry. The level will be compared between intervention and control group (percentage)
measure: Placenta 25(OH)D
time frame: 1 year
description: Placenta 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
measure: Placenta vitamin A
time frame: 1 year
description: Placenta vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
measure: Placenta zinc
time frame: 1 year
description: Placenta zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
measure: Placenta IL-1B
time frame: 1 year
description: Placenta IL-1B will be measured by ELISA. The level will be compared between intervention and control group (pg/mL)
measure: Serum zinc
time frame: 1 year
description: Serum zinc will be measured by ICP-MS. The level will be compared between intervention and control group (ug/L)
measure: Serum 25(OH)D
time frame: 1 year
description: Serum 25(OH)D will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
measure: Serum vitamin A
time frame: 1 year
description: Serum vitamin A will be measured by LC-MS. The level will be compared between intervention and control group (ng/mL)
arm group label: Intervention
arm group type: Placebo Comparator
description: Nifedipin 4x10 mg oral
Dexamethasone 2x6 mg iv for 2 days
Zinc 50 mg/day
Beta-carotene 25,000 IU
Vitamin D3 50,000 IU/weekly
arm group label: Control
arm group type: Active Comparator
description: Nifedipin 4x10 mg
Dexamethasone 2x6 mg iv for 2 days
intervention type: Drug
intervention name: Zinc
description: included in intervention arm
arm group label: Intervention
other name: Zinc Picolinate 50 mg
intervention type: Drug
intervention name: Nifedipine
description: included in intervention and control arm
arm group label: Control
arm group label: Intervention
other name: Nifedipine 10 mg
intervention type: Drug
intervention name: Beta Carotene
description: included in intervention arm
arm group label: Intervention
other name: Beta carotene 25,000 IU
intervention type: Drug
intervention name: Vitamin D3
description: included in intervention arm
arm group label: Intervention
other name: Cholecalciferol 50,000 IU
intervention type: Drug
intervention name: Dexamethasone
description: included in intervention and control arm
arm group label: Control
arm group label: Intervention
other name: Dexamethasone 6 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Rima Irwinda
investigator title: MD
mesh term: Premature Birth
mesh term: Vitamin D
mesh term: Cholecalciferol
mesh term: Beta Carotene
mesh term: Zinc
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Nifedipine
mesh term: BB 1101
mesh term: Carotenoids
mesh term: Picolinic acid
sharing ipd: Yes
ipd description: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
submitted: February 27, 2019
returned: March 19, 2019