Trial reportBMC pediatrics2026
Effect of vitamin D administration on sepsis score and C-reactive protein (CRP) levels in preterm infants with neonatal sepsis: a randomized controlled trial.
Trial report in BMC pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07245277 (The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis
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Authors and funding
3 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundNeonatal sepsis remains a leading cause of mortality in preterm infants. While Vitamin D possesses immunomodulatory properties, evidence for its adjuvant role in sepsis is limited. This study evaluated the efficacy of two Vitamin D doses (400 IU vs. 800 IU) on clinical sepsis scores and C-reactive protein (CRP) levels.
methodsAn open-label, randomized controlled trial was conducted in Indonesia (August-December 2025) involving preterm infants (28-36 weeks) with sepsis. Patients were randomized into three groups for 7 days: (1) Controls (antibiotics only, nil per os [NPO]), (2) Vitamin D 400 IU/day, and (3) Vitamin D 800 IU/day. The open-label design was necessary due to the difference in feeding status (enteral vs. NPO). Outcomes included changes in the modified Töllner score, Sepsis Prediction Score (SPS), and serum CRP. Analysis was performed using ANCOVA and UNIANOVA, with laboratory analysts blinded to group allocation to strengthen the internal validity.
resultsA total of 78 neonates were enrolled and randomized. After exclusions (n = 17), the final analysis included 61 neonates (Control: n = 23; 400 IU: n = 19; 800 IU: n = 19) with largely comparable baseline characteristics. Baseline Vitamin D deficiency was prevalent (73.7%). Both intervention groups showed significantly greater improvements in modified Töllner score and SPS compared to controls (p < 0.001), with no significant difference between the 400 IU and 800 IU doses (p = 1.000). Although CRP levels stabilized in the intervention groups and gained a significant increase in controls, adjusted inter-group differences at day 7 were not significant (p = 0.421). Mortality was higher in the control group (48.6%) compared to the intervention groups (p < 0.001); however, this is likely influenced by the greater baseline severity and cardiovascular instability inherent to their NPO status. Reported adverse events (Grade 1) did not require protocol cessation.
conclusionVitamin D administration (400 and 800 IU/day) significantly improves sepsis scores in preterm infants with comparable clinical effectiveness between doses, supporting its potential as an effective adjuvant therapy in neonatal sepsis.
trial registrationClinicalTrials.gov NCT07245277. Registered 22 September 2025 - Retrospectively registered.
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