Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05419973 |
Other study ID # |
UH22030108 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 15, 2022 |
Est. completion date |
March 2023 |
Study information
Verified date |
June 2022 |
Source |
Hasanuddin University |
Contact |
Sri Hardiyanti Putri, MD |
Phone |
628114499339 |
Email |
srihardiyantiputri[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.