Two Different Regimens of Oral Vitamin D in Treatment of Early Onset Neonatal Sepsis

Abstract Background Newborns are more susceptible to infections as both innate and adaptive immune systems are not entirely developed. Associations have been shown between vitamin D deficiency and respiratory tract infections and sepsis. Vitamin D also has immunomodulatory effects on immune function. Objectives To compare (lower dose of oral Vitamin D 400 IU versus doubling of it) in full term neonates with early-onset sepsis (EOS). Methods A randomized controlled trial (RCT) comprised sixty six (66) full term neonates with EOS, admitted to the Neonatal Intensive Care Unit of Children's Hospital, Ain Shams University and the NICU of El Ahrar Teaching Hospital in Zagazig. We excluded preterm newborns, neonates on NPO (nothing per os), neonates with maternal risk factors, such as chorioamnionitis, neonates delivered at home and those with major congenital abnormalities. All patients were assessed according to Newborn Scale of Sepsis. The cases were randomly assigned into 3 groups; group A (who received lower dose of oral Vitamin D 400 IU and group B, who received 800 IU/day of vitamin D3 and group C who didn’t receive any vitamin D supplementation. Serum concentrations of 25(OH)D were measured at enrollment and on recovery. Results The mean serum level of 25 (OH) vitamin D in all 66 newborns with early onset sepsis included in the study was 18.12 ± 3.6 ng/ml and it was low and considered insufficient. 78.8% of enrolled infants were vitamin D- insufficient at enrollment in the three groups. The study shows significant relation between the mean of serum vitamin D on recovery and regimen of vitamin D supplemented to the newborns; where 55 % of the patients in group A became sufficient on recovery, 75 % of the patients of group B became sufficient on recovery and 25% of group C became sufficient on recovery. Mean age of recovery of group A, B and C were 10.4±3.6, 8.7±3.2 and 11.3±3.8 respectively with significant difference between group B and group C (mean±SD) being 8.7±3.2 versus 11.3±3.8 respectively with p- value= 0.024. None of the infants enrolled in the study had signs of vitamin D toxicity or serum levels exceeding 80-100 ng/ml upon recovery. Conclusions Vitamin D supplementation has a role in recovery of full term neonates suffering from sepsis.