Vitamin D DeficiencyVITADiNCT05419973
Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)
An observational study of Vitamin D Deficiency, run by Hasanuddin University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Anthropometric measurement for pregnant women, Anthropometric measurement for infants and Blood sampling
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 May 2022to Mar 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women in third trimester of pregnancy in Makassar, Surabaya, Mataram who are selected during the screening test.
Who may be able to join
- Women in third trimester of pregnancy
- Agree to include their babies in this study
Who cannot join
- History of abortion
- Suffering from hypertension or preeclampsia
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Hasanuddin University
Makassar, South Sulawesi, 90245
Sri Hardiyanti Putri, MD, 628114499339, srihardiyantiputri@gmail.com
Bahrul Fikri, MD, PhD, 6282123997492, bahrulfikri@unhas.ac.id
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Anthropometric measurement for pregnant women, Anthropometric measurement for infants, Blood sampling
- Keywords
- Vitamin D in Infants
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measurement for pregnant womenOther
Weight, length, upper arm circumference
Anthropometric measurement for infantsOther
birth weight, length, head circumference, nutritional status
Blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Anthropometric measurement for infants; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Levels
Measured by blood sample collection
Measured: August 2022 - February 2023
Secondary outcomes (5)
Hemoglobin levels
Measured by blood sample collection
Measured: August 2022 - February 2023
IgE
Measured by blood sample collection
Measured: August 2022 - February 2023
Atopic Dermatitis
Skin rash, itchiness, patchy skin
Measured: August 2022 - February 2023
Diarrhea
Incidence of diarrhea
Measured: August 2022 - February 2023
Hypertension
Blood pressure obtained during visits
Measured: August 2022 - February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start15 May 2022
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Sri Hardiyanti Putri, Sp.A, Hasanuddin University
- Investigators
- Sri Hardiyanti Putri, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419973
- Sponsor's protocol ID
- UH22030108
- Acronym
- VITADi
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are going to share individual participant data that underlie results in this publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)
- ClinicalTrials.gov ID
- NCT05419973
- Acronym / sponsor ID
- VITADi / UH22030108
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D in Infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Anthropometric measurement for pregnant women, Other: Blood samplingWomen 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. |
| Infants | – | Other: Anthropometric measurement for infants, Other: Blood samplingBabies 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women in third trimester of pregnancy in Makassar, Surabaya, Mataram who are selected during the screening test.
Key inclusion criteria (2 listed)
- Women in third trimester of pregnancy
- Agree to include their babies in this study
Key exclusion criteria (2 listed)
- History of abortion
- Suffering from hypertension or preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric measurement for pregnant womenWeight, length, upper arm circumference | Other | Pregnant Women |
| Anthropometric measurement for infantsbirth weight, length, head circumference, nutritional status | Other | Infants |
| Blood sampling3 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 | Infants, Pregnant Women |
Primary outcome
Vitamin D Levels
Time frame: August 2022 - February 2023
Measured by blood sample collection
5 secondary outcomes
Hemoglobin levels
Time frame: August 2022 - February 2023
IgE
Time frame: August 2022 - February 2023
Atopic Dermatitis
Time frame: August 2022 - February 2023
Diarrhea
Time frame: August 2022 - February 2023
Hypertension
Time frame: August 2022 - February 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- 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.Link provided by the sponsor.
- 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).Link provided by the sponsor.
- Cyprian, F., Lefkou, E., Varoudi, K., \& Girardi, G. (2019). Immunomodulatory Effects of Vitamin D in Pregnancy and Beyond. Frontiers in Immunology, 10.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We are going to share individual participant data that underlie results in this publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sri Hardiyanti Putri, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sri Hardiyanti Putri, MD (628114499339, srihardiyantiputri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D Levels (time frame: August 2022 - February 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.