Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. The main questions it aims to answer are:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D 400 IU for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Baseline (day-0) and at day-7 |
Not provided
Not provided
Inclusion Criteria:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reni Ghrahani, MD, Ph.D | Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran | Study Director |
| Fiva A Kadi, MD, Ph.D | Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasan Sadikin General Hospital | Bandung | West Java | 40161 | Indonesia | ||
| Rumah Sakit Umum Daerah Bandung Kiwari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27079965 | Background | 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. | |
| Background | 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. | ||
| 25102323 |
Not provided
Not provided
All IPD that underlie results in a publication
Beginning 3 months and ending 1 year after the publication of results
A proposal that describes planned analyses must be submitted and a data sharing agreement must be signed. The proposal must be submitted to the principal investigator's email. The statistical methods for analyses of the proposal must be approved by independent review.
Not provided
There were no events or washout periods between participant enrollment and assignment.
Participants were recruited from the neonatal intensive care unit (NICU) and neonatal high care unit (NHCU) from 2 medical centers; at a regional hospital and a tertiary care hospital in Bandung, Indonesia, between August 2025 and December 2025
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics Only | Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting. |
| FG001 | Vitamin D 400 IU | 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. |
| FG002 | Vitamin D 800 IU | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics Only | Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting. |
| BG001 | Vitamin D 400 IU | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | Score | Baseline (day-0) and at day-7 |
|
From enrollment until the end of follow-up, up to 7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotics Only | Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Angelica Wijaya | Universitas Padjadjaran | 6281313996911 | michelle13002@mail.unpad.ac.id |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2025 | Dec 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2025 | Oct 21, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vitamin D | Drug | Vitamin D 800 IU for 7 days |
|
|
| Bandung |
| West Java |
| 40233 |
| Indonesia |
| Background |
| 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. |
| 31241441 | Background | 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. |
| 42116025 | Derived | 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. |
| Transitioned to nil per os status during monitoring |
|
| BG002 | Vitamin D 800 IU | 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. |
| BG003 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gestational Age | Median | Inter-Quartile Range | weeks |
|
| Birth Weight | Mean | Standard Deviation | gram |
|
| Respiratory support | Count of Participants | Participants |
|
| Vitamin D concentration in participants | Median | Inter-Quartile Range | ng/mL |
|
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.
| OG002 | Vitamin D 800 IU | 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. |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | Score | Baseline (day-0) and at day-7 |
|
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mg/dL | Baseline (day-0) and at day-7 |
|
|
|
|
| 8 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Vitamin D 400 IU | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Vitamin D 800 IU | 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. | 1 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Non-invasive ventilation |
|
| Ventilator |
|
|
| Δ Day 1 and 7 |
|
|
| Δ Day 1 and 7 |
|