Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05419973
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2022-06-11
Brief Title:
Vitamin D Levels in Umbilical Cord and Its Impact on Infant and Childrens Health VITADi Study
Sponsor:
Hasanuddin University
Organization:
Hasanuddin University
Study Overview
Official Title:
Vitamin D Levels in Umbilical Cord and Its Impact on Infant and Childrens Health VITADi Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITADi
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 15 ml each to measure the complete blood count and other 15 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 15 ml each to measure the complete blood count and other 15 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 ordinalnumeric 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
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 15 ml each to measure the complete blood count and other 15 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 15 ml each to measure the complete blood count and other 15 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 ordinalnumeric 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None