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Mechanism of placental calcium transport through investigation of calcium intake and vitamin D status to maximize bone health in pregnant and lactating women

Status Approved

  • First Submitted Date

    2020/04/16

  • Registered Date

    2020/06/12

  • Last Updated Date

    2020/06/06

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005118
    Unique Protocol ID CNUH-2018-125
    Public/Brief Title Mechanism of placental calcium transport through investigation of calcium intake and vitamin D status to maximize bone health in pregnant and lactating women
    Scientific Title Mechanism of placental calcium transport through investigation of calcium intake and vitamin D status to maximize bone health in pregnant and lactating women
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2018-125
    Approval Date 2018-06-22
    Institutional Review Board Name Chonnam National University Hospital Institutional Review Borad
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jong Woon Kim
    Title Professor
    Telephone +82-62-220-6388
    Affiliation Chonnam National University Hospital
    Address Chonnam National University, 77, Yongbong-ro, Buk-gu, Gwangju, Republic of Korea
    Contact Person for Public Queries
    Name Clara Yongjoo Park
    Title Professor
    Telephone +82-62-530-1354
    Affiliation Chonnam National University
    Address Chonnam National University, 77, Yongbong-ro, Buk-gu, Gwangju, Republic of Korea
    Contact Person for Updating Information
    Name Clara Yongjoo Park
    Title Professor
    Telephone +82-62-530-1354
    Affiliation Chonnam National University
    Address Chonnam National University, 77, Yongbong-ro, Buk-gu, Gwangju, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-01-07 Actual
    Target Number of Participant 210
    Primary Completion Date 2024-02-29 , Anticipated
    Study Completion Date 2024-02-29 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University
    Recruitment Status Recruiting
    Date of First Enrollment 2019-01-07 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-01-07 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Others
    Project ID 2018R1C1B3003777
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Objective 1: Identify the mechanism of calcium mobilization (mother to fetus)
    1) Analysis of the expression pattern of calcium-related proteins in the blood hormones, blood minerals and placenta of maternal and newborns.
    2) Identify the differences in maternal and fetal SNP genotypes by maternal and fetal SNP genotypes.
    
    Objective 2: Correlation between calcium intake and vitamin D status and maternal and fetal bone mineral density in postpartum pregnancy, lactation, after weaning.
    1) Correlation between maternal/neonatal bone mineral density and serum vitamin D, hormones, minerals and maternal dietary intake and maternal/neonatal bone mineral density of multiple births. 
    2) Correlation between breastfeeding duration, breastfeeding amount, serum vitamin D, hormone, mineral concentrations, dietary intake and bone mineral density at 6 months after birth/weaning.
    3) Correlation between serum vitamin D, blood hormone, serum mineral concentrations, dietary intake, and bone mineral density/bone resorption in mothers and neonates at 12 months after birth.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 210
    Cohort/Group Number 4
    Cohort/
    Group 1

    Cohort/Group Label

    Pregnant women carrying singletons

    Cohort/Group Description

    - mothers over 20 years old who are scheduled to deliver in the delivery room of Chonnam National University Hospital Obstetrics and Gynecology
    - pregnant women with singletons gestational age of 24 weeks and 0 days or over
    - food and nutrient intake will be assessed by food frequency questionaire and serum and plasma will be analyzed for nutrient status and mineral metabolism before delivery, at weaning (or 6 months postpartum), and 1 year postpartum (cordblood will also be collected and analyzed)
    -bone mineral density will be assessed by DXA immediately after birth, at weaning (or 6 months postpartum), and 1 year postpartum 
    - DNA will ba analyzed from blood samples
    Cohort/
    Group 2

    Cohort/Group Label

    Pregnant women carrying multiples

    Cohort/Group Description

    - mothers over 20 years old who are scheduled to deliver in the delivery room of Chonnam National University Hospital Obstetrics and Gynecology
    - pregnant women with multiples gestational age of 24 weeks and 0 days or over
    - food and nutrient intake will be assessed by food frequency questionaire and serum and plasma will be analyzed for nutrient status and mineral metabolism before delivery, at weaning (or 6 months postpartum), and 1 year postpartum (cordblood will also be collected and analyzed)
    -bone mineral density will be assessed by DXA immediately after birth, at weaning (or 6 months postpartum), and 1 year postpartum 
    - DNA will ba analyzed from blood samples
    Cohort/
    Group 3

    Cohort/Group Label

    Child of singleton pregnancy

    Cohort/Group Description

    - Children born from mothers of group1 
    - Birth weight, birth length, head circumference at birth, Apgar scores, medical conditions will be assessed
    - Weight, length, head circumference, medical history, food intake will be assessed at 1 year of age
    Cohort/
    Group 4

    Cohort/Group Label

    Child of multiple pregnancy

    Cohort/Group Description

    - Children born from mothers of group2
    - Birth weight, birth length, head circumference at birth, Apgar scores, medical conditions will be assessed
    - Weight, length, head circumference, medical history, food intake will be assessed at 1 year of age
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description
    whole blood, serum, plasma, placenta
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    - mothers over 20 years old who are scheduled to deliver in the delivery room of Chonnam National University Hospital Obstetrics and Gynecology
    - singleton, multiple pregnant women after 24 weeks and 0 days of pregnancy
    Sampling Method
    Non-probablity sampling
    Condition(s)/Problem(s)    Not Applicable-Quality of life 

    pregnancy, postpartum period, weaning
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    1Day~No Limit

    Description

    - mothers over 20 years old who are scheduled to deliver in the delivery room of Chonnam National University Hospital Obstetrics and Gynecology
    - singleton, multiple pregnant women after 24 weeks and 0 days of pregnancy and neonates/infants
    Exclusion Criteria
    - Intrauterine fetal death
    - Pregnancy with more than 4 fetuses
    - Pregnant women/neonates/infants who have a disease affecting the bone metabolism (liver, kidney, thyroid, parathyroid disease, etc.) or who take medicine
    - Pregnant women/neonates diagnosed with genetic disease
    - Pregnant women/neonates/infants with fractures
    - If it is difficult to examination after 6 months and 1 year after delivery
    - Pregnant women with difficulty remembering or reporting dietary intake
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    maternal blood, fetal cord blood, neonate blood, bone mineral density, placenta
    Timepoint
    at delivery, at 6 months after delivery or weaning, at 12 months after delivery
    Secondary Outcome(s) 1
    Outcome
    dietary survey using the food frequency questionnaire for the last 3 or 6 months
    Timepoint
    before delivery, at 6 months after delivery or weaning, at 12 months after delivery
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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