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Mediators in Preterm Infants With Late-onset Sepsis

A Randomized Controlled Trial

Abdel-Hady, Hesham*; Yahia, Sohier*; Megahed, Ahmed*; Mosbah, Abeer; Seif, Basma*; Nageh, Eman*; Bhattacharjee, Indrani; Aly, Hany

Journal of Pediatric Gastroenterology and Nutrition: April 2019 - Volume 68 - Issue 4 - p 578–584
doi: 10.1097/MPG.0000000000002238
Original Articles: Nutrition

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-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 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- α 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.

*Department of Pediatrics

Department of Clinical Pathology, Faculty of Medicine-Mansoura University, Mansoura, Egypt

Department of Neonatology, Cleveland Clinic Children's Hospital, Cleveland, OH.

Address correspondence and reprint requests to Hany Aly, MD, Cleveland Clinic Children's Hospital, Department of Neonatology, 9500 Euclid Avenue, Suite M31-37, Cleveland, OH 44195 (e-mail:

Received 16 July, 2018

Accepted 6 December, 2018

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The authors report no conflicts of interest.

The study was registered at clinical (identifier: NCT02273843).

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© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,