Trial Outcomes & Findings for Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis (NCT NCT07245277)

Last Updated: 2026-02-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

78 participants

Primary outcome timeframe

Baseline (day-0) and at day-7

Results posted on

2026-02-05

Participant Flow

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

There were no events or washout periods between participant enrollment and assignment.

Participant milestones

Participant milestones
Measure	Antibiotics Only Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	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.	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.
Overall Study STARTED	35	20	23
Overall Study COMPLETED	23	19	19
Overall Study NOT COMPLETED	12	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Antibiotics Only Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	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.	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.
Overall Study Death	8	0	1
Overall Study Achieved enteral nutrition tolerance during monitoring	4	0	0
Overall Study Transitioned to nil per os status during monitoring	0	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics Only n=23 Participants Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	Vitamin D 400 IU n=19 Participants 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 n=19 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Customized Age	4 days n=23 Participants	10 days n=19 Participants	6 days n=19 Participants	6 days n=61 Participants
Sex: Female, Male Female	11 Participants n=23 Participants	7 Participants n=19 Participants	10 Participants n=19 Participants	28 Participants n=61 Participants
Sex: Female, Male Male	12 Participants n=23 Participants	12 Participants n=19 Participants	9 Participants n=19 Participants	33 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Gestational Age	33 weeks n=23 Participants	32 weeks n=19 Participants	32 weeks n=19 Participants	32 weeks n=61 Participants
Birth Weight	1579.5 gram STANDARD_DEVIATION 568.3 • n=23 Participants	1536.7 gram STANDARD_DEVIATION 386.4 • n=19 Participants	1674.3 gram STANDARD_DEVIATION 397.0 • n=19 Participants	1595.7 gram STANDARD_DEVIATION 462.2 • n=61 Participants
Respiratory support Low flow	1 Participants n=23 Participants	1 Participants n=19 Participants	1 Participants n=19 Participants	3 Participants n=61 Participants
Respiratory support Non-invasive ventilation	5 Participants n=23 Participants	5 Participants n=19 Participants	6 Participants n=19 Participants	16 Participants n=61 Participants
Respiratory support Ventilator	17 Participants n=23 Participants	13 Participants n=19 Participants	12 Participants n=19 Participants	42 Participants n=61 Participants
Vitamin D concentration in participants	9.36 ng/mL n=23 Participants	16.35 ng/mL n=19 Participants	20.50 ng/mL n=19 Participants	11.67 ng/mL n=61 Participants

PRIMARY outcome

Timeframe: Baseline (day-0) and at day-7

Outcome measures

Outcome measures
Measure	Antibiotics Only n=23 Participants Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	Vitamin D 400 IU n=19 Participants 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 n=19 Participants 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.
Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days Day-0	7 Score Interval 6.0 to 10.0	7 Score Interval 6.0 to 9.0	8 Score Interval 7.0 to 9.0
Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days Day-7	9 Score Interval 8.0 to 12.0	2 Score Interval 0.0 to 6.0	1 Score Interval 0.0 to 6.0
Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days Δ Day 1 and 7	1 Score Interval 0.0 to 4.0	-5 Score Interval -7.0 to -1.0	-6 Score Interval -8.0 to -2.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiotics Only n=23 Participants Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	Vitamin D 400 IU n=19 Participants 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 n=19 Participants 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.
Change From Baseline in the Sepsis Prediction Score After 7 Days Day-0	4 Score Interval 3.0 to 4.0	3 Score Interval 2.0 to 4.0	3 Score Interval 2.0 to 4.0
Change From Baseline in the Sepsis Prediction Score After 7 Days Day-7	4 Score Interval 2.0 to 5.0	0 Score Interval 0.0 to 2.0	0 Score Interval 0.0 to 2.0
Change From Baseline in the Sepsis Prediction Score After 7 Days Δ Day 1 and 7	0 Score Interval -1.0 to 1.0	-2 Score Interval -3.0 to -1.0	-2 Score Interval -3.0 to -1.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiotics Only n=23 Participants Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.	Vitamin D 400 IU n=19 Participants 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 n=19 Participants 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.
Change From Baseline in the C-Reactive Protein Levels After 7 Days Δ Day 1 and 7	0.25 mg/dL Interval -0.06 to 4.3	-0.06 mg/dL Interval -4.16 to 1.82	-0.93 mg/dL Interval -7.99 to 0.42
Change From Baseline in the C-Reactive Protein Levels After 7 Days Day-0	0.26 mg/dL Interval 0.08 to 1.92	0.36 mg/dL Interval 0.13 to 5.93	1.19 mg/dL Interval 0.63 to 11.41
Change From Baseline in the C-Reactive Protein Levels After 7 Days Day-7	1.71 mg/dL Interval 0.12 to 9.19	0.54 mg/dL Interval 0.04 to 5.25	0.82 mg/dL Interval 0.19 to 5.82

Adverse Events

Antibiotics Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Vitamin D 400 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D 800 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Angelica Wijaya

Universitas Padjadjaran

Phone: 6281313996911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place