Could vitamin d help fight sepsis in preterm infants?
NCT ID NCT07245277
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether giving vitamin D alongside antibiotics helps premature babies with sepsis recover better. Researchers gave 78 preterm infants either antibiotics alone or antibiotics plus 400 or 800 IU of vitamin D daily for 7 days. They tracked changes in sepsis scores and C-reactive protein levels to see if vitamin D made a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin D (cholecalciferol)
- What this could lead to
- If it works, adding vitamin D to standard antibiotics could help reduce infection severity in preterm babies with sepsis.
- What could go wrong
- This is a small, completed Phase 4 trial with only 78 infants. Results may not apply to all preterm babies, and vitamin D may not provide significant benefit over antibiotics alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
78 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 84 days
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. 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. 2. Parents or legal guardians are willing to participate in the study and sign the informed consent form. Exclusion Criteria: 1. Patients with major congenital malformations such as anencephaly, encephalocele, holoprosencephaly, hydrocephalus, meningomyelocele, spina bifida, omphalocele, gastroschisis, or congenital heart disease. 2. If during the 7-day monitoring period, a patient who was initially able to feed develops a medical condition requiring fasting (NPO). 3. If during the 7-day monitoring period, a patient who initially had a medical condition requiring fasting is later able to feed again.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hasan Sadikin General Hospital
Bandung, West Java, 40161, Indonesia
-
Rumah Sakit Umum Daerah Bandung Kiwari
Bandung, West Java, 40233, Indonesia
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Other studies related to the condition(s) this trial covers.
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