NCT07245277

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: All
• Age: 0 Days – 84 Days
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
DRUG	Vitamin D	Vitamin D 400 IU for 7 days
DRUG	Vitamin D	Vitamin D 800 IU for 7 days

Timeline

• Start date: 2025-08-02
• Primary completion: 2025-12-01
• Completion: 2025-12-08
• First posted: 2025-11-24
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

2 sites across 1 country: Indonesia