<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/NCT02190396</url>
  </required_header>
  <id_info>
    <org_study_id>VIT D PLACENTAL CALCIFICATION</org_study_id>
    <nct_id>NCT02190396</nct_id>
  </id_info>
  <brief_title>Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?</brief_title>
  <official_title>Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zekai Tahir Burak Women's Health Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zekai Tahir Burak Women's Health Research and Education Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The&#xD;
      role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at&#xD;
      placental pathologies is unknown. Placental calcification is usually thought to be a&#xD;
      physiological aging process. Nevertheless, it can be a pathological change resulting from the&#xD;
      effects of environmental factors on the placenta. The aim of the investigators study was to&#xD;
      evaluate the relationship between placental calcification and maternal and cord blood&#xD;
      25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at&#xD;
      term and their consequences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood&#xD;
      25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia,&#xD;
      gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and&#xD;
      increase in fetal respiratory infections and infant wheezing [1].&#xD;
&#xD;
      Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by&#xD;
      intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the&#xD;
      use of sun screens, age, dressing style and seasonal changes [1]. Placenta plays an important&#xD;
      role in Vitamin D metabolism during pregnancy and some independent risk factors increasing&#xD;
      the risk of placental dysfunction at fetomaternal interface also influence vitamin D&#xD;
      metabolism [2,3]. Nevertheless, there can be a pathological change resulting from the effects&#xD;
      of environmental factors on the placenta .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with low birth weight.</measure>
    <time_frame>Three months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of delivery with cesarean section.</measure>
    <time_frame>Three months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Placental calcification of Grade 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>No placental calcification noted, the control group.</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal venous and umbilical cordon blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Foreknown systemic diseases, multiple pregnancy, smoking cigarettes, receiving vitamin&#xD;
             D or calcium supplementation.&#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>
  <overall_official>
    <last_name>Ali O Ersoy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zekai Tahir Burak Maternity Teaching Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Wuertz C, Gilbert P, Baier W, Kunz C. Cross-sectional study of factors that influence the 25-hydroxyvitamin D status in pregnant women and in cord blood in Germany. Br J Nutr. 2013 Nov;110(10):1895-902. doi: 10.1017/S0007114513001438. Epub 2013 May 23.</citation>
    <PMID>23697742</PMID>
  </reference>
  <reference>
    <citation>Cho GJ, Hong SC, Oh MJ, Kim HJ. Vitamin D deficiency in gestational diabetes mellitus and the role of the placenta. Am J Obstet Gynecol. 2013 Dec;209(6):560.e1-8. doi: 10.1016/j.ajog.2013.08.015. Epub 2013 Aug 14.</citation>
    <PMID>23954530</PMID>
  </reference>
  <reference>
    <citation>Saffery R, Ellis J, Morley R. A convergent model for placental dysfunction encompassing combined sub-optimal one-carbon donor and vitamin D bioavailability. Med Hypotheses. 2009 Dec;73(6):1023-8. doi: 10.1016/j.mehy.2009.03.057. Epub 2009 Oct 9.</citation>
    <PMID>19819084</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 12, 2014</last_update_submitted>
  <last_update_submitted_qc>July 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zekai Tahir Burak Women's Health Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Ali Ozgur Ersoy</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Calcium</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Placental calcification.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Calcinosis</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/NCT02190396
org study id: VIT D PLACENTAL CALCIFICATION
nct id: NCT02190396
lead sponsor: 
has dmc: Yes
Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The
      role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at
      placental pathologies is unknown. Placental calcification is usually thought to be a
      physiological aging process. Nevertheless, it can be a pathological change resulting from the
      effects of environmental factors on the placenta. The aim of the investigators study was to
      evaluate the relationship between placental calcification and maternal and cord blood
      25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at
      term and their consequences.
Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood
      25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia,
      gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and
      increase in fetal respiratory infections and infant wheezing [1].

      Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by
      intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the
      use of sun screens, age, dressing style and seasonal changes [1]. Placenta plays an important
      role in Vitamin D metabolism during pregnancy and some independent risk factors increasing
      the risk of placental dysfunction at fetomaternal interface also influence vitamin D
      metabolism [2,3]. Nevertheless, there can be a pathological change resulting from the effects
      of environmental factors on the placenta .
observational model: Case-Control
time perspective: Prospective
measure: Number of participants with low birth weight.
time frame: Three months
measure: Percentage of delivery with cesarean section.
time frame: Three months
arm group label: Group 1
description: Placental calcification of Grade 3
arm group label: Group 2
description: No placental calcification noted, the control group.
Maternal venous and umbilical cordon blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali O Ersoy
role: Principal Investigator
affiliation: Medical doctor
facility: 
country: Turkey
citation: Wuertz C, Gilbert P, Baier W, Kunz C. Cross-sectional study of factors that influence the 25-hydroxyvitamin D status in pregnant women and in cord blood in Germany. Br J Nutr. 2013 Nov;110(10):1895-902. doi: 10.1017/S0007114513001438. Epub 2013 May 23.
PMID: 23697742
citation: Cho GJ, Hong SC, Oh MJ, Kim HJ. Vitamin D deficiency in gestational diabetes mellitus and the role of the placenta. Am J Obstet Gynecol. 2013 Dec;209(6):560.e1-8. doi: 10.1016/j.ajog.2013.08.015. Epub 2013 Aug 14.
PMID: 23954530
citation: Saffery R, Ellis J, Morley R. A convergent model for placental dysfunction encompassing combined sub-optimal one-carbon donor and vitamin D bioavailability. Med Hypotheses. 2009 Dec;73(6):1023-8. doi: 10.1016/j.mehy.2009.03.057. Epub 2009 Oct 9.
PMID: 19819084
responsible party type: Principal Investigator
investigator affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
investigator full name: Ali Ozgur Ersoy
investigator title: Medical Doctor
mesh term: Vitamin D Deficiency
mesh term: Calcinosis