Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)

Study Overview
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Brief Summary
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This study is a cohort study that aims to assess the relationship between Vitamin D Levels in infant and the risk of anemia, atopic dermatitis, diarrhea and cardiovascular disorders in newborn. The subjects of this study are 100 women who met the inclusion criteria, which are in their third trimester of pregnancy and agree to be included in this study. These subjects then will be examined for their weight using standardized CEBA digital scale, height, upper arm circumference, and blood sampling will also be done to these women to measure their vitamin D levels, calcium, parathyroid hormone, ferritin, Fe serum, IL-16, IL-10. When subjects give birth, the babies will also be included in this study. Anthropometric examination will also be done on the babies, to measure their birth weight, birth length, and head circumference. Blood samples will also be taken from their umbilical cord to assess their complete blood count, ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10. All subjects then will be monitored, and home visits will be done when the babies reach 3 months old and 6 months old. An assessment of the incidence of diarrhea, atopic dermatitis, and an assessment of cardiovascular disorders (checking pulse and blood pressure) will be carried out during the visit. At the end of the study, venous blood sampling will be taken to see levels of vitamin D, calcium, parathyroid hormone, routine complete blood count, serum Fe, and ferritin, then data analysis is performed.

Detailed Description
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Participants of this study are women in the third semester of pregnancy, who consented to be included with their babies in this study. Firstly, the parents will be given explanation regarding the study, and informed consent will be signed if they agree to participate. All the pregnant women who met the criteria will be recorded for their name, age, parity, birth and medical history. Anthropometric examination will be done on the pregnant women, to measure weight using standardized CEBA digital scale, height and upper arm circumference. Blood sampling will also be done to measure complete blood count, ferritin, Fe serum, vitamin D levels, calcium, parathyroid hormone, IL-6 and IL-10. 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.

Official Title
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Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Other: Anthropometric measurement for pregnant women
* Other: Anthropometric measurement for infants
* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in third trimester of pregnancy Agree to include their babies in this study Exclusion Criteria: History of abortion Suffering from hypertension or preeclampsia
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>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. | Other: Anthropometric measurement for pregnant women<br>* Weight, length, upper arm circumference<br>Other: Blood sampling<br>* 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.<br>|
| Infants<br>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. | Other: Anthropometric measurement for infants<br>* birth weight, length, head circumference, nutritional status<br>Other: Blood sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D Levels | Measured by blood sample collection | August 2022 - February 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin levels | Measured by blood sample collection | August 2022 - February 2023 | 
| IgE | Measured by blood sample collection | August 2022 - February 2023 | 
| Atopic Dermatitis | Skin rash, itchiness, patchy skin | August 2022 - February 2023 | 
| Diarrhea | Incidence of diarrhea | August 2022 - February 2023 | 
| Hypertension | Blood pressure obtained during visits | August 2022 - February 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D in Infants