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

NCT07245277 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-02-05

Study results available
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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.

Conditions

  • Neonatal Sepsis
  • Preterm Infants

Interventions

DRUG

Vitamin D

Vitamin D 400 IU for 7 days

DRUG

Vitamin D

Vitamin D 800 IU for 7 days

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Reni Ghrahani, MD, Ph.D · Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran

  • Fiva A Kadi, MD, Ph.D · Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
84 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-02
Primary Completion
2025-12-01
Completion
2025-12-08

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245277 on ClinicalTrials.gov