Vitamin D and Inflammatory Mediators in Preterm Infants with Late-Onset Sepsis: A Randomized Controlled Trial

OBJECTIVE: To evaluate biochemical and clinical effects of two 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/d of vitamin D3. Serum concentrations of 25(OH)D, TNF-α 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 percent 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- α concentrations decreased at one week and at discharge in both groups without differences between groups. The two 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 two dosing regimens did not differ in clinical or biochemical changes.