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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Hasan Sadikin General Hospital
RECRUITING
Bandung
Rumah Sakit Umum Daerah Bandung Kiwari
RECRUITING
Bandung
Contact Information
Primary
Michelle A Wijaya, MD
michelleangelicawijaya@yahoo.com
6281313996911
Time Frame
Start Date: 2025-08-02
Estimated Completion Date: 2025-12-10
Participants
Target number of participants: 57
Treatments
No_intervention: Antibiotics only
Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Fakultas Kedokteran Universitas Padjadjaran

This content was sourced from clinicaltrials.gov

Similar Clinical Trials