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
CRIS Registration Number |
KCT0005118 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Others |
Project ID | 2018R1C1B3003777 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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 |
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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 |
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Biospecimen Collection & Archiving |
: DNA Collect & Archive: Sample with DNA |
Biospecimen Description | whole blood, serum, plasma, placenta |
9. Subject Eligibility
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 |
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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 |
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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)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | maternal blood, fetal cord blood, neonate blood, bone mineral density, placenta |
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Timepoint | at delivery, at 6 months after delivery or weaning, at 12 months after delivery |
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Secondary Outcome(s) 1 | ||
Outcome | dietary survey using the food frequency questionnaire for the last 3 or 6 months |
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Timepoint | before delivery, at 6 months after delivery or weaning, at 12 months after delivery |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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