Clinical trial NCT05419973: Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)
Official title: Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Keywords: Vitamin D in Infants
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women in third trimester of pregnancy in Makassar, Surabaya, Mataram who are selected during the screening test.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D Levels
timeFrame: August 2022 - February 2023
Secondary outcomes:
measure: Hemoglobin levels
timeFrame: August 2022 - February 2023
measure: IgE
timeFrame: August 2022 - February 2023
measure: Atopic Dermatitis
timeFrame: August 2022 - February 2023
measure: Diarrhea
timeFrame: August 2022 - February 2023
measure: Hypertension
timeFrame: August 2022 - February 2023
Other outcomes:
Locations:
city: Makasar
country: Indonesia
facility: Hasanuddin University
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Sri Hardiyanti Putri, MD
role: PRINCIPAL_INVESTIGATOR
References: