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. Address correspondence and reprint requests to Hany Aly, MD, Cleveland Clinic Children's, Department of Neonatology, 9500 Euclid Avenue, Suite M31-37, Cleveland, OH 44195 (e-mail: alyh@ccf.org). Received 16 July, 2018 Accepted 6 December, 2018 Conflict of Interest and Source of Funding: All authors have nothing to declare. The study was registered at clinical trials.gov (identifier: NCT02273843). Conflict of Interest: The authors declare no conflict of interest. Authors' contributions Hesham Abdel-Hady: Contributed to the concept and design of the work. He wrote the paper, approved the final version and agreed to be accountable for all aspects of the work. Sohier Yahia: Contributed to data acquisition. She wrote the first draft of the paper. She approved the final version and agreed to be accountable for all aspects of the work. Ahmed Megahed: Contributed to data acquisition. He approved the final version and agreed to be accountable for all aspects of the work. Abeer Mosbah: Performed the microbiological analysis. She approved the final version and agreed to be accountable for all aspects of the work. Basma Seif: Contributed to data acquisition. She wrote the first draft of the paper. She approved the final version and agreed to be accountable for all aspects of the work. Eman Nageh: Contributed to data acquisition. She wrote the first draft of the paper. She approved the final version and agreed to be accountable for all aspects of the work. Indrani Bhattacharjee: She contributed to the analysis and interpretation of the data. She assisted with writing the paper and the figures. She approved the final version and agreed to be accountable for all aspects of the work. Hany Aly: Contributed to the concept and design of the work. Revised the manuscript, approved the final version and agreed to be accountable for all aspects of the work. Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). © 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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