Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)
NCT ID: NCT05419973
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-05-15
2023-03-31
Brief Summary
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Detailed Description
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After the subjects give birth, the babies who met the criteria (aterm, birth weight \> 2500 grams, with no congenital abnormalities and acute infection at birth) will also be included in this study. Measurement of birth weight, birth length, and head circumference will be carried out along with blood sampling by taking 3 ml of blood from umbilical cord, 1,5 ml each to measure the complete blood count, and other 1,5 ml to measure ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10. Subjects will be monitored for 6 months, and two home visits will be done throughout the study at the age of 3 months and 6 months. During the visits, subjects will be measured for their weight, length, head circumference, as well as their nutritional status. Parents and guardians will also be asked questions regarding the incidence of diarrhea, allergic manifestations such as rash, and assessment will be made based on Hanifin Rajka criteria. At the age of 6 months old, blood sampling will be done again by taking 3 ml of the blood, 1,5 ml each to measure the complete blood count, and other 1,5 ml to measure ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10.
The collected data then will be grouped based on the purpose and type of data, then univariate analysis and bivariate analysis will be performed. Univariate analysis will describe the characteristics of the basic data, in the form of frequency, mean value, standard deviation, and range. Meanwhile bivariate analysis such as Wilcoxon test will be performed to to analyse data with independent variables with an ordinal/numeric scale, the data are not normally distributed and have different variances. Mann-Whitney test will also be performed test to compare ordinal or numeric scale variables whose data are not normally distributed and have different variances between two unpaired groups.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Women
Women in third semester of pregnancy who are willing to include their babies as samples for the next study, no history of abortion, and not suffering from hypertension and preeclampsia.
Anthropometric measurement for pregnant women
Weight, length, upper arm circumference
Blood sampling
3 ml of blood will be taken, 1,5 ml each to measure the complete blood count, and other 1,5 ml to measure ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10.
Infants
Babies born from mothers who are willing to be included in the study, aterm, with birth weight more than 2500 grams. No congenital abnormalities at birth and no acute infection at birth.
Anthropometric measurement for infants
birth weight, length, head circumference, nutritional status
Blood sampling
3 ml of blood will be taken, 1,5 ml each to measure the complete blood count, and other 1,5 ml to measure ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10.
Interventions
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Anthropometric measurement for pregnant women
Weight, length, upper arm circumference
Anthropometric measurement for infants
birth weight, length, head circumference, nutritional status
Blood sampling
3 ml of blood will be taken, 1,5 ml each to measure the complete blood count, and other 1,5 ml to measure ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10.
Eligibility Criteria
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Inclusion Criteria
* Agree to include their babies in this study
Exclusion Criteria
* Suffering from hypertension or preeclampsia
FEMALE
No
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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dr. Sri Hardiyanti Putri, Sp.A
Principal Investigator, Pediatrician, Teaching Staff at Pediatric Department Hasanuddin University
Principal Investigators
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Sri Hardiyanti Putri, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Hasanuddin University
Makassar, South Sulawesi, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Sri Hardiyanti Putri, MD
Role: primary
Bahrul Fikri, MD, PhD
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Atkinson, MA, Melamed, ML, Kumar, J., Roy, CN, Miller, ER, 3rd, Furth, SL, \& Fadrowski, JJ (2014). Vitamin D, race, and risk for anemia in children. The Journal of pediatrics, 164(1), 153-158.e1.
Cadario, F., Savastio, S., Pozzi, E., Capelli, A., Dondi, E., Gatto, M., Zaffaroni, M., \& Bona, G. (2013). Vitamin D status in cord blood and newborns: Ethnic differences. Italian Journal of Pediatrics, 39(1).
Cyprian, F., Lefkou, E., Varoudi, K., \& Girardi, G. (2019). Immunomodulatory Effects of Vitamin D in Pregnancy and Beyond. Frontiers in Immunology, 10.
Other Identifiers
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UH22030108
Identifier Type: -
Identifier Source: org_study_id