Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial

Objective: To evaluate biochemical and clinical effects of 2 different doses of vitamin D supplementation in preterm infants with late-onset sepsis (LOS). Study Design: A double blinded randomized controlled stratified trial included preterm infants with gestational age (GA) >= 28 weeks with LOS. Subjects were randomly assigned to receive 400 or 800 IU/day of vitamin D3. Serum concentrations of 25(OH) D, TNF-alpha, and IL-6 were measured at enrollment, 7 days after vitamin D supplementation, and at 40 weeks of postmenstrual age (PMA). Short-term outcomes and growth parameters were assessed. Results: A total of 50 infants were enrolled, 25 in each group. Seventy-six percentage of enrolled infants were vitamin D-deficient at enrollment in both groups whereas only one infant in the 400 IU and none in the 800 IU group remained deficient at 40 week's PMA; vitamin D concentrations at 40 weeks PMA were 54.8 +/- 35.1 and 67.4 +/- 37.1 ng/mL, respectively, P = 0.01). None of the infants enrolled in the study had signs of vitamin D toxicity. Serum pro-inflammatory cytokines IL-6 and TNF-alpha concentrations decreased at 1 week and at discharge in both groups without differences between groups. The 2 groups did not differ in anthropometric measurements, duration of oxygen and respiratory support, duration of antimicrobial use, length of hospital stay, and mortality. Conclusions: A dose of 400 IU of vitamin D was adequate to treat vitamin D deficiency in the majority of premature infants with LOS. The 2 dosing regimens did not differ in clinical or biochemical changes.