Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants.
OBJECTIVE
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 (400 IU) versus a bolus dose (50 000 IU) 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 50 nmol/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 (154 nmol/L, 95% confidence interval (CI) 131-177) was higher than the daily group (48 nmol/L, 95% CI 42-54) at 1-2 weeks of age. This was reversed at 3-4 months, (65 nmol/L, 95% CI 59-71) compared with the daily group (81 nmol/L, 95% CI 77-85). More infants in the single bolus group achieved vitamin D repletion (100 vs. 31%) at 1-2 weeks. By 3-4 months, both groups achieved similar vitamin D repletion rates (91 vs. 89%). Mean adjusted total serum calcium in the bolus group were normal at 1-2 weeks (2.73 mmol/L) and 3-4 months (2.55 mmol/L).


CONCLUSIONS
Single bolus dosing of 50 000 IU cholecalciferol achieves higher 25OHD repletion rates at 1-2 weeks of age compared with daily dosing, but repletion rates were similar by 3-4 months. There was no hypercalcaemia documented with single bolus dosing in this study.
Women's and Children's Division, Sunshine Hospital, Melbourne, Victoria, Australia.
Julie
J
Huynh
Women's and Children's Division, Sunshine Hospital, Melbourne, Victoria, Australia.
Thao
T
Lu
Melbourne Epicentre, University of Melbourne, University of Melbourne, Melbourne, Victoria, Australia.|Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Danny
D
Liew
Monash Pathology, Monash Health, Melbourne, Victoria, Australia.|Department of Medicine, Monash University, Melbourne, Victoria, Australia.
James Cg
JC
Doery
Monash Pathology, Monash Health, Melbourne, Victoria, Australia.
Ronald
R
Tudball
Women's and Children's Division, Sunshine Hospital, Melbourne, Victoria, Australia.
Madeleine
M
Jona
Women's and Children's Division, Sunshine Hospital, Melbourne, Victoria, Australia.
Roisin
R
Bhamjee
Women's and Children's Division, Sunshine Hospital, Melbourne, Victoria, Australia.|Department of Paediatrics, University of Melbourne, Sunshine Hospital, Melbourne, Victoria, Australia.|Royal Children's Hospital, Melbourne, Victoria, Australia.|Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.
Christine P
CP
Rodda
D000284:Administration, Oral; D000328:Adult; D001315:Australia; D002118:Calcium / Q000097:blood; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D017063:Outcome Assessment, Health Care; D014807:Vitamin D / Q000008:administration & dosage / Q000031:analogs & derivatives*; D014808:Vitamin D Deficiency / Q000188:drug therapy*; D055815:Young Adult
D014807:Vitamin D; C104450:25-hydroxyvitamin D; D002118:Calcium

25OHD
; cholecalciferol; infant; newborn; vitamin D