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

NCT05419973 | Unknown DMC

• 1 other identifier: UH22030108
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D in Infants

Outcome Measures

Primary Outcomes (1)

• Vitamin D Levels

  Measured by blood sample collection

  August 2022 - February 2023

Secondary Outcomes (5)

• Hemoglobin levels

  August 2022 - February 2023

• IgE

  August 2022 - February 2023

• Atopic Dermatitis

  August 2022 - February 2023

• Diarrhea

  August 2022 - February 2023

• Hypertension

  August 2022 - February 2023

Study Arms (2)

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; Other: Blood sampling

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: Anthropometric measurement for infants; Other: Blood sampling

Interventions

Anthropometric measurement for pregnant women OTHER

Weight, length, upper arm circumference

Pregnant Women

Anthropometric measurement for infants OTHER

birth weight, length, head circumference, nutritional status

Infants

Blood sampling OTHER

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; Pregnant Women

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Women in third trimester of pregnancy
• Agree to include their babies in this study

You may not qualify if:

• History of abortion
• Suffering from hypertension or preeclampsia

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sri Hardiyanti Putri, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sri Hardiyanti Putri, MD

CONTACT

628114499339; srihardiyantiputri@gmail.com

Bahrul Fikry, MD, PhD

CONTACT

6282123997492; bahrulfikri@unhas.ac.id

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatrician, Teaching Staff at Pediatric Department Hasanuddin University

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 15, 2022
• Study Start: May 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: The data will be shared by email sent by the primary investigator

Locations

ID (1)