Neonatal SepsisPhase 4NCT07245277

Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis

A Phase 4 study testing Vitamin D in people with Neonatal Sepsis and Preterm Infants, run by Universitas Padjadjaran at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn the effect of vitamin D as an adjunctive therapy for preterm neonates with sepsis measured by the outcomes, which are sepsis score and C-reactive protein after 7 days. Read more about this study

Who is it for?: Ages 0 to 84 days
Conditions the study is for: Neonatal Sepsis, Preterm Infants
What is being tested?: Vitamin D
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 2 sitesIndonesia
Study dates: 2 Aug 2025to 8 Dec 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 to 84 days
All sexes
No healthy volunteers
Child

Who may be able to join

Inclusion criteria for the case group used in this study are neonates (aged 0-28 days or with a maximum postmenstrual age of 42 weeks) with a gestational age of 28-36 weeks who are treated in the Neonatal High Care Unit (NHCU) and Neonatal Intensive Care Unit (NICU) at Dr. Hasan Sadikin General Hospital, Bandung, and Bandung Kiwari Hospital, Bandung and who meet the following inclusion criteria:
Patients diagnosed with neonatal sepsis based on positive blood or cerebrospinal fluid cultures, or who meet the criteria for suspected sepsis with a Rodwell hematologic scoring system result of ≥3.
Parents or legal guardians are willing to participate in the study and sign the informed consent form.

Who cannot join

Patients with major congenital malformations such as anencephaly, encephalocele, holoprosencephaly, hydrocephalus, meningomyelocele, spina bifida, omphalocele, gastroschisis, or congenital heart disease.
If during the 7-day monitoring period, a patient who was initially able to feed develops a medical condition requiring fasting (NPO).
If during the 7-day monitoring period, a patient who initially had a medical condition requiring fasting is later able to feed again.

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

Hasan Sadikin General Hospital
Bandung, West Java, 40161
Rumah Sakit Umum Daerah Bandung Kiwari
Bandung, West Java, 40233

Other trials in Indonesia

About this study

Official title: The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis

Is there a difference in the results of the sepsis score (Modified Tollner Score and Sepsis Prediction Score) between groups of preterm neonates with sepsis who were given vitamin D as adjuvant therapy at doses of 400 IU/day, 800 IU/day, and those who were only given antibiotics?

Is there a difference in CRP levels between groups of preterm neonates with sepsis who were given vitamin D as adjuvant therapy at doses of 400 IU/day, 800 IU/day, and those who were only given antibiotics?

Participants will be divided into 3 groups:

Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.

Group 2 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 400 IU once daily for 7 days.

Group 3 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 800 IU once daily for 7 days.

Read the detailed description

The target population in this study is preterm neonates diagnosed with sepsis. This is a multicenter study. The accessible population in this study is patients who are treated in the Neonatal High Care Unit (NHCU) and Neonatal Intensive Care Unit (NICU) at Dr. Hasan Sadikin General Hospital Bandung and Bandung Kiwari Hospital, who meet the inclusion criteria and do not meet the exclusion criteria, and whose parents or guardians are willing to participate in the study by signing the informed consent form.

Conditions: Neonatal Sepsis, Preterm Infants
Being tested: Vitamin D
Keywords: adjuvant therapy, neonatal sepsis, preterm infants, vitamin D
Medical subject headings: Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin DDrug
Also called L-VIT D3
Vitamin D 400 IU for 7 days
Vitamin DDrug
Also called L-VIT D3
Vitamin D 800 IU for 7 days

Study groups in NCT07245277
Study group	Role	What they receive
Antibiotics only	No intervention	Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.
Vitamin D 400 IU	Active comparator	Group 2 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 400 IU once daily for 7 days. Receives: Drug: Vitamin D
Vitamin D 800 IU	Active comparator	Group 3 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 800 IU once daily for 7 days. Receives: Drug: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days
Modified Töllner sepsis scoring system consists of clinical parameters including appearance, microcirculation, hypotonia, bradycardia/tachycardia, apnea of prematurity, respiratory distress, hepatomegaly, gastrointestinal symptoms, leucocyte count, Immature to Total Neutrophil (I/T) ratio, thrombocytopenia, C-reactive protein.
Minimum value: 0 Maximum value: 26 Higher scores mean a worse outcome for neonatal sepsis
Measured: Baseline (day-0) and at day-7
Change From Baseline in the Sepsis Prediction Score After 7 Days
Sepsis Prediction Score consists of clinical parameters including body temperature, decrease feeding volume/residuals, platelet counts, blood glucose changes, C-reactive protein, circulatory changes, increase of oxygen requirement, deterioration of respiratory function.
Minimum value: 0 Maximum value: 8 Higher scores mean a worse outcome for neonatal sepsis
Measured: Baseline (day-0) and at day-7
Change From Baseline in the C-Reactive Protein Levels After 7 Days
The blood sample was taken from the neonate to test for C-reactive protein (CRP) on day 0 and day 7.
Minimum value: 0 Higher scores mean a worse outcome for neonatal sepsis
Measured: Baseline (day-0) and at day-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20258 Dec 2025

First posted24 Nov 2025
Study start2 Aug 2025
Primary completion1 Dec 2025
Study completion8 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Neonatal SepsisStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07245277
Sponsor's protocol ID: DP. 04.03/D.XIV.6.5/337/2025
Status last verified: Jan 2026
First submitted: 22 Sep 2025
Last updated: 5 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication

Publications

Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
PubMed 27079965
Kamsiah K, Hasibuan BS, Arto KS. The relationship between vitamin D levels and clinical outcomes of neonatal sepsis in Haji Adam Malik Hospital Medan, Indonesia. Open Access Maced J Med Sci. 2021;9(B):698-703.
Cetinkaya M, Cekmez F, Buyukkale G, Erener-Ercan T, Demir F, Tunc T, Aydin FN, Aydemir G. Lower vitamin D levels are associated with increased risk of early-onset neonatal sepsis in term infants. J Perinatol. 2015 Jan;35(1):39-45. doi: 10.1038/jp.2014.146. Epub 2014 Aug 7.
PubMed 25102323
Hagag AA, El Frargy MS, Houdeeb HA. Therapeutic Value of Vitamin D as an Adjuvant Therapy in Neonates with Sepsis. Infect Disord Drug Targets. 2020;20(4):440-447. doi: 10.2174/1871526519666190626141859.
PubMed 31241441
Wijaya MA, Kadi FA, Ghrahani R. Effect of vitamin D administration on sepsis score and C-reactive protein (CRP) levels in preterm infants with neonatal sepsis: a randomized controlled trial. BMC Pediatr. 2026 May 11;26(1):621. doi: 10.1186/s12887-026-06844-0.
PubMed 42116025

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neonatal Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis
ClinicalTrials.gov ID: NCT07245277
Acronym / sponsor ID: DP. 04.03/D.XIV.6.5/337/2025
Conditions: Neonatal Sepsis, Preterm Infants
Keywords: adjuvant therapy, neonatal sepsis, preterm infants, vitamin D
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Universitas PadjadjaranUniversity, hospital or other
Study start: 2 Aug 2025 (actual)
Primary completion: 1 Dec 2025 (actual)
Study completion: 8 Dec 2025 (actual)
First posted: 24 Nov 2025 (actual)
Results: Posted 5 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will be divided into 3 groups:

Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.

Group 2 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 400 IU once daily for 7 days.

Group 3 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 800 IU once daily for 7 days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Antibiotics only	No intervention	–Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.
Vitamin D 400 IU	Active comparator	Drug: Vitamin DGroup 2 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 400 IU once daily for 7 days.
Vitamin D 800 IU	Active comparator	Drug: Vitamin DGroup 3 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 800 IU once daily for 7 days.

Who may qualify

Ages: 0 to 84 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Inclusion criteria for the case group used in this study are neonates (aged 0-28 days or with a maximum postmenstrual age of 42 weeks) with a gestational age of 28-36 weeks who are treated in the Neonatal High Care Unit (NHCU) and Neonatal Intensive Care Unit (NICU) at Dr. Hasan Sadikin General Hospital, Bandung, and Bandung Kiwari Hospital, Bandung and who meet the following inclusion criteria:
Patients diagnosed with neonatal sepsis based on positive blood or cerebrospinal fluid cultures, or who meet the criteria for suspected sepsis with a Rodwell hematologic scoring system result of ≥3.
Parents or legal guardians are willing to participate in the study and sign the informed consent form.

Key exclusion criteria (3 listed)

Patients with major congenital malformations such as anencephaly, encephalocele, holoprosencephaly, hydrocephalus, meningomyelocele, spina bifida, omphalocele, gastroschisis, or congenital heart disease.
If during the 7-day monitoring period, a patient who was initially able to feed develops a medical condition requiring fasting (NPO).
If during the 7-day monitoring period, a patient who initially had a medical condition requiring fasting is later able to feed again.

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
Vitamin DAlso: L-VIT D3Vitamin D 400 IU for 7 days	Drug	Vitamin D 400 IU
Vitamin DAlso: L-VIT D3Vitamin D 800 IU for 7 days	Drug	Vitamin D 800 IU

Primary outcome

Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days
Time frame: Baseline (day-0) and at day-7
Modified Töllner sepsis scoring system consists of clinical parameters including appearance, microcirculation, hypotonia, bradycardia/tachycardia, apnea of prematurity, respiratory distress, hepatomegaly, gastrointestinal symptoms, leucocyte count, Immature to Total Neutrophil (I/T) ratio, thrombocytopenia, C-reactive protein. Minimum value: 0 Maximum value: 26 Higher scores mean a worse outcome for neonatal sepsis
Change From Baseline in the Sepsis Prediction Score After 7 Days
Time frame: Baseline (day-0) and at day-7
Sepsis Prediction Score consists of clinical parameters including body temperature, decrease feeding volume/residuals, platelet counts, blood glucose changes, C-reactive protein, circulatory changes, increase of oxygen requirement, deterioration of respiratory function. Minimum value: 0 Maximum value: 8 Higher scores mean a worse outcome for neonatal sepsis
Change From Baseline in the C-Reactive Protein Levels After 7 Days
Time frame: Baseline (day-0) and at day-7
The blood sample was taken from the neonate to test for C-reactive protein (CRP) on day 0 and day 7. Minimum value: 0 Higher scores mean a worse outcome for neonatal sepsis

Results and safety

Results posted to the registry on 5 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Antibiotics Only	35	23
Vitamin D 400 IU	20	19
Vitamin D 800 IU	23	19

Primary outcome: Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days

Time frame: Baseline (day-0) and at day-7. Median (Inter-Quartile Range). Unit: Score

Measure	Antibiotics Only n = 23	Vitamin D 400 IU n = 19	Vitamin D 800 IU n = 19
Day-0	7 (6 to 10)	7 (6 to 9)	8 (7 to 9)
Day-7	9 (8 to 12)	2 (0 to 6)	1 (0 to 6)
Δ Day 1 and 7	1 (0 to 4)	-5 (-7 to -1)	-6 (-8 to -2)

Antibiotics Only vs Vitamin D 400 IU vs Vitamin D 800 IU: p <0.001, ANCOVA

Primary outcome: Change From Baseline in the Sepsis Prediction Score After 7 Days

Time frame: Baseline (day-0) and at day-7. Median (Inter-Quartile Range). Unit: Score

Measure	Antibiotics Only n = 23	Vitamin D 400 IU n = 19	Vitamin D 800 IU n = 19
Day-0	4 (3 to 4)	3 (2 to 4)	3 (2 to 4)
Day-7	4 (2 to 5)	0 (0 to 2)	0 (0 to 2)
Δ Day 1 and 7	0 (-1 to 1)	-2 (-3 to -1)	-2 (-3 to -1)

Antibiotics Only vs Vitamin D 400 IU vs Vitamin D 800 IU: p <0.001, ANCOVA

Primary outcome: Change From Baseline in the C-Reactive Protein Levels After 7 Days

Time frame: Baseline (day-0) and at day-7. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Antibiotics Only n = 23	Vitamin D 400 IU n = 19	Vitamin D 800 IU n = 19
Day-0	0.26 (0.08 to 1.92)	0.36 (0.13 to 5.93)	1.19 (0.63 to 11.41)
Day-7	1.71 (0.12 to 9.19)	0.54 (0.04 to 5.25)	0.82 (0.19 to 5.82)
Δ Day 1 and 7	0.25 (-0.06 to 4.30)	-0.06 (-4.16 to 1.82)	-0.93 (-7.99 to 0.42)

Antibiotics Only vs Vitamin D 400 IU vs Vitamin D 800 IU: p = 0.030, ANCOVA

Adverse events

Time frame: From enrollment until the end of follow-up, up to 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antibiotics Only	0 of 35 (0%)	0 of 35 (0%)	8 of 35
Vitamin D 400 IU	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Vitamin D 800 IU	0 of 23 (0%)	0 of 23 (0%)	1 of 23

Limitations and caveats (from the sponsor): Baseline difference: the control group (antibiotic only) consisted solely of neonates kept NPO (nil per os) for medical necessity. In contrast, the intervention groups (vitamin D 400 and 800 IU) were required to be on enteral nutrition. Repeated CRP testing was performed on day 7, although serial monitoring on day 3 is considered ideal. This constraint was due to limitations in blood sampling and laboratory resources at our hospital.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27079965Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
BackgroundKamsiah K, Hasibuan BS, Arto KS. The relationship between vitamin D levels and clinical outcomes of neonatal sepsis in Haji Adam Malik Hospital Medan, Indonesia. Open Access Maced J Med Sci. 2021;9(B):698-703.
Background: PubMed 25102323Cetinkaya M, Cekmez F, Buyukkale G, Erener-Ercan T, Demir F, Tunc T, Aydin FN, Aydemir G. Lower vitamin D levels are associated with increased risk of early-onset neonatal sepsis in term infants. J Perinatol. 2015 Jan;35(1):39-45. doi: 10.1038/jp.2014.146. Epub 2014 Aug 7.
Background: PubMed 31241441Hagag AA, El Frargy MS, Houdeeb HA. Therapeutic Value of Vitamin D as an Adjuvant Therapy in Neonates with Sepsis. Infect Disord Drug Targets. 2020;20(4):440-447. doi: 10.2174/1871526519666190626141859.
Derived from this study: PubMed 42116025Wijaya MA, Kadi FA, Ghrahani R. Effect of vitamin D administration on sepsis score and C-reactive protein (CRP) levels in preterm infants with neonatal sepsis: a randomized controlled trial. BMC Pediatr. 2026 May 11;26(1):621. doi: 10.1186/s12887-026-06844-0.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a 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.

Reni Ghrahani, MD, Ph.D study director

Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran

Fiva A Kadi, MD, Ph.D study director

Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D in people with Neonatal Sepsis and Preterm Infants, run by Universitas Padjadjaran at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days (time frame: Baseline (day-0) and at day-7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245277, which also lists 5 linked publications.

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 5 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.