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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: Anthropometric measurement for pregnant women; Other: Blood sampling; Other: Anthropometric measurement for infants

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sri Hardiyanti Putri, MD; Phone Number: 628114499339; Email: srihardiyantiputri@gmail.com
• Study Contact Backup: Name: Bahrul Fikry, MD, PhD; Phone Number: 6282123997492; Email: bahrulfikri@unhas.ac.id

Study Locations

• Indonesia
  • South Sulawesi
    • Makasar, South Sulawesi, Indonesia, 90245
      • Recruiting
      • Hasanuddin University
      • Contact: Sri Hardiyanti Putri, MD; Phone Number: 628114499339; Email: srihardiyantiputri@gmail.com
      • Contact: Bahrul Fikri, MD, PhD; Phone Number: 6282123997492; Email: bahrulfikri@unhas.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women in third trimester of pregnancy in Makassar, Surabaya, Mataram who are selected during the screening test.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Anthropometric measurement for pregnant women; Weight, length, upper arm circumference; Other: 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.	Other: 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.; Other: Anthropometric measurement for infants; birth weight, length, head circumference, nutritional status

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Principal Investigator: Sri Hardiyanti Putri, MD, Hasanuddin University

Publications and helpful links

Helpful Links

• Adams, JS, & Hewison, M. (2010). Update in vitamin D. Journal of Clinical Endocrinology and Metabolism, 95(2), 471-478.
• Akcakus, M., Koklu, E., Slave, N., Kula, M., Kurtoglu, S., & Koklu, S. (2006). The relationship between birthweight, 25-hydroxyvitamin D concentrations and bone mineral status in neonates. Annals of Tropical Paediatrics, 26(4), 267-275.
• Aluisio, AR, Maroof, Z., Chandramohan, D., Bruce, J., Zulf Mughal, M., Bhutta, Z., Walraven, G., Masher, MI, Ensink, JHJ, & Manaseki-Holland, S. (2013). Vitamin D3 supplementation and childhood diarrhea: A randomized controlled trial. Pediatrics, 132(4).
• 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).
• Cerami, C. (2017). Iron Nutriture of the Fetus, Neonate, Infant, and Child. Annals of Nutrition and Metabolism, 71(3), 8-14.
• Cyprian, F., Lefkou, E., Varoudi, K., & Girardi, G. (2019). Immunomodulatory Effects of Vitamin D in Pregnancy and Beyond. Frontiers in Immunology, 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: June 11, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D in Infants
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: UH22030108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are going to share individual participant data that underlie results in this publication
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: The data will be shared by email sent by the primary investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No