Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants

Aim: There are no published data to demonstrate the efficacy of bolus dose vitamin D in newborn infants. The study sought to evaluate this alternative approach of supplementation. Methods: This single centre, open randomised controlled trial was conducted from August 2013 to May 2014. It compared the efficacy and safety of daily (400IU) versus a bolus dose (50000IU) of cholecalciferol in newborn infants of vitamin D deficient mothers. The primary outcome measure was the rate of 25 hydroxyvitamin D (25OHD) repletion-defined as 25OHD greater than 50nmol/L. The secondary objective was determining safety using adjusted total serum calcium. Results: Of 70 eligible infants, 36 received a daily dose and 34 received a single high-dose cholecalciferol. Mean 25OHD in the bolus group (154nmol/L, 95% confidence interval (CI) 131-177) was higher than the daily group (48nmol/L, 95% CI 42-54) at 1-2weeks of age. This was reversed at 3-4months, (65nmol/L, 95% CI 59-71) compared with the daily group (81nmol/L, 95% CI 77-85). More infants in the single bolus group achieved vitamin D repletion (100 vs. 31%) at 1-2weeks. By 3-4months, both groups achieved similar vitamin D repletion rates (91 vs. 89%). Mean adjusted total serum calcium in the bolus group were normal at 1-2weeks (2.73mmol/L) and 3-4months (2.55mmol/L). Conclusion: Single bolus dosing of 50000IU cholecalciferol achieves higher 25OHD repletion rates at 1-2weeks of age compared with daily dosing, but repletion rates were similar by 3-4months. There was no hypercalcaemia documented with single bolus dosing in this study.