xml: <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/NCT06002035</url>
    </required_header>
    <id_info>
      <org_study_id>2023002</org_study_id>
      <nct_id>NCT06002035</nct_id>
    </id_info>
    <brief_title>Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion</brief_title>
    <official_title>The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jianmei Xia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First People's Hospital of Hangzhou</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The observational study is to compare vitamin D deficiency and related indicators among&#xD;
        different spontaneous abortions in describe female reproductive health.The main question aim&#xD;
        to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin&#xD;
        D.&#xD;
  &#xD;
        Participants, who visit the RSA specialty clinic, will provide medical history information,&#xD;
        regularly exam based on the condition, following up on pregnancy status.Participants will be&#xD;
        asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect&#xD;
        after treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes&#xD;
        tested voluntarily, plasma VD content and the level of anticardiolipin antibody.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">July 25, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</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>Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1</measure>
      <time_frame>average of 1 year</time_frame>
      <description>Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as empty sac which refers to the absence of a fetal sac or embryo bud (the amniotic sac is empty).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as biochemical pregnancy which refers to the phenomenon where the sperm and egg combine but fail to return to the uterus for implantation, leading to miscarriage along with menstruation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as loss of fetal heart rate which refers to the cessation of fetal heartbeat during pregnancy leading to miscarriage.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as spontaneous miscarriage in large months (greater than 12 weeks but less than 28 weeks) which refers to the cause of fetal death in the uterus, vaginal bleeding or flowing and abdominal pain leading to miscarriage.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as failure of fetal heart rate which the inability of the fetus to detect heartbeat leading to miscarriage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The difference of age in different number of spontaneous abortions</measure>
      <time_frame>one day</time_frame>
      <description>Record patients' age through initial visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference of BMI in different number of spontaneous abortion</measure>
      <time_frame>one day</time_frame>
      <description>Record patients' height and weight through initial visit, and then calculate according to BMI formula.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions</measure>
      <time_frame>dynamic monitoring, average of half of a year</time_frame>
      <description>Use a three-dimensional ultrasound diagnostic instrument(GEVoluson-E10 or E8, USA) with a frequency of 5-9 MHz intracavity probe (non pregnancy) or 3-7 MHz abdominal probe (pregnancy) to examine bilateral S/D. Unpregnant patients were in mid luteal phase(5-7 days after ovulation), while pregnant patients were at 10 weeks of pregnancy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions</measure>
      <time_frame>a month</time_frame>
      <description>use SNP gene chips to detect the embryonic chromosomes in spontaneous abortion; extract the genomic DNA of aborted embryo tissue, perform whole genome chromosome detection and determine whether the corresponding fragment or site is abnormal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of plasma VD content in spontaneous abortions before and after supplying vitamin D</measure>
      <time_frame>average of 1 year</time_frame>
      <description>VD content was detected by liquid chromatography-tandem mass spectrometry using DISIGNS reagent. Dynamically monitor plasma VD at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D</measure>
      <time_frame>average of 1 year</time_frame>
      <description>ACA level was detected by enzyme-linked immunosorbent assay using EUROIMMUN reagent. dynamically monitor plasma anticardiolipin antibody at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">1421</enrollment>
    <condition>Vitamin D Deficiency</condition>
    <condition>Recurrent Spontaneous Abortion</condition>
    <arm_group>
      <arm_group_label>patients without spontaneous abortion(SA0)</arm_group_label>
      <description>The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients with a spontaneous abortion(SA1)</arm_group_label>
      <description>The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients with RSA (SA2 and above)</arm_group_label>
      <description>The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Binom Vitamin D drops</intervention_name>
      <description>Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added</description>
      <arm_group_label>patients with RSA (SA2 and above)</arm_group_label>
      <arm_group_label>patients with a spontaneous abortion(SA1)</arm_group_label>
      <arm_group_label>patients without spontaneous abortion(SA0)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women of childbearing age visited the RSA specialty clinic of Hangzhou First People's&#xD;
          Hospital from January 2021 to June 2023, conducting a prospective clinical study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of patients without spontaneous abortion;&#xD;
  &#xD;
            -  Clinical diagnosis of patients with a spontaneous abortion;&#xD;
  &#xD;
            -  Clinical diagnosis of patients with recurrent pontaneous abortions;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with chromosomal abnormalities in RSA couples, such as balanced&#xD;
               translocation;&#xD;
  &#xD;
            -  Patients who take VD preparations or related VD supplements within 3 months before&#xD;
               treatment;&#xD;
  &#xD;
            -  Patients with a combination of certain malignant tumors and severe mental illness.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jianmei Xia</last_name>
      <role>Study Director</role>
      <affiliation>First People's Hospital of Hangzhou</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jianmei Xia</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310006</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
      <investigator_full_name>Jianmei Xia</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abortion, Spontaneous</mesh_term>
      <mesh_term>Vitamin D Deficiency</mesh_term>
      <mesh_term>Recurrence</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>
  
  
text: 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/NCT06002035
  org study id: 2023002
  nct id: NCT06002035
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The observational study is to compare vitamin D deficiency and related indicators among
        different spontaneous abortions in describe female reproductive health.The main question aim
        to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin
        D.
  
        Participants, who visit the RSA specialty clinic, will provide medical history information,
        regularly exam based on the condition, following up on pregnancy status.Participants will be
        asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect
        after treatment.
  Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes
        tested voluntarily, plasma VD content and the level of anticardiolipin antibody.
  observational model: Case-Control
  time perspective: Prospective
  measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1
  time frame: average of 1 year
  description: Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as empty sac which refers to the absence of a fetal sac or embryo bud (the amniotic sac is empty).
  measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
  time frame: average of half of a year
  description: Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as biochemical pregnancy which refers to the phenomenon where the sperm and egg combine but fail to return to the uterus for implantation, leading to miscarriage along with menstruation.
  measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3
  time frame: average of half of a year
  description: Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as loss of fetal heart rate which refers to the cessation of fetal heartbeat during pregnancy leading to miscarriage.
  measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4
  time frame: average of half of a year
  description: Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as spontaneous miscarriage in large months (greater than 12 weeks but less than 28 weeks) which refers to the cause of fetal death in the uterus, vaginal bleeding or flowing and abdominal pain leading to miscarriage.
  measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5
  time frame: average of half of a year
  description: Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as failure of fetal heart rate which the inability of the fetus to detect heartbeat leading to miscarriage.
  measure: The difference of age in different number of spontaneous abortions
  time frame: one day
  description: Record patients' age through initial visit.
  measure: The difference of BMI in different number of spontaneous abortion
  time frame: one day
  description: Record patients' height and weight through initial visit, and then calculate according to BMI formula.
  measure: The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions
  time frame: dynamic monitoring, average of half of a year
  description: Use a three-dimensional ultrasound diagnostic instrument(GEVoluson-E10 or E8, USA) with a frequency of 5-9 MHz intracavity probe (non pregnancy) or 3-7 MHz abdominal probe (pregnancy) to examine bilateral S/D. Unpregnant patients were in mid luteal phase(5-7 days after ovulation), while pregnant patients were at 10 weeks of pregnancy.
  measure: The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions
  time frame: a month
  description: use SNP gene chips to detect the embryonic chromosomes in spontaneous abortion; extract the genomic DNA of aborted embryo tissue, perform whole genome chromosome detection and determine whether the corresponding fragment or site is abnormal.
  measure: The change of plasma VD content in spontaneous abortions before and after supplying vitamin D
  time frame: average of 1 year
  description: VD content was detected by liquid chromatography-tandem mass spectrometry using DISIGNS reagent. Dynamically monitor plasma VD at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.
  measure: The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D
  time frame: average of 1 year
  description: ACA level was detected by enzyme-linked immunosorbent assay using EUROIMMUN reagent. dynamically monitor plasma anticardiolipin antibody at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.
  arm group label: patients without spontaneous abortion(SA0)
  description: The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.
  arm group label: patients with a spontaneous abortion(SA1)
  description: The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.
  arm group label: patients with RSA (SA2 and above)
  description: The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added.
  intervention type: Dietary Supplement
  intervention name: Binom Vitamin D drops
  description: Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added
  arm group label: patients with RSA (SA2 and above)
  arm group label: patients with a spontaneous abortion(SA1)
  arm group label: patients without spontaneous abortion(SA0)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jianmei Xia
  role: Study Director
  affiliation: First People's Hospital of Hangzhou
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: First People's Hospital of Hangzhou
  investigator full name: Jianmei Xia
  investigator title: Deputy Chief Physician
  mesh term: Abortion, Spontaneous
  mesh term: Vitamin D Deficiency
  mesh term: Recurrence
  mesh term: Vitamin D