Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants
Julie Huynh, Thao Lu, Danny Liew, James CG Doery, Ronald Tudball, Madeleine Jona, Roisin Bhamjee, Christine P Rodda
JOURNAL OF PAEDIATRICS AND CHILD HEALTH | WILEY | Published : 2017
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 (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..View full abstract
We thank the families and their infants who participated in the vitamin D in newborns study, midwives at Sunshine Hospital who helped with recruitment and the following: Clinical Trials Pharmacy Department, Western Health, Sunshine Hospital, St Albans, Victoria, Australia. Ray Kong, Nhi Dinh and Lei Wei Ching. Women's and Children's Division, Sunshine Hospital, St Albans, Victoria, Australia, Dr Martin Wright (Head of Paediatrics), Associate Professor Glyn Teale (Head of Obstetrics and Gynaecology). North West Academic Centre, University of Melbourne, Sunshine Hospital, St Albans, Victoria, Australia, Former head of North West Academic Centre, Professor Peter Ebeling, Director, Monash University Department of Medicine, Monash Medical Centre, Clayton, Australia. The study was funded by the womens' and children's division Sunshine Hospital, St Albans, Australia for the provision of trial medications and pharmacy costs. The Australian Institute for MusculoSkeletal Science, Sunshine Hospital, St Albans, Australia funded the publication, and conference costs related to this study. Bayer Health donated Infant-Pentavite in kind. Neither of these bodies had a role in the design of the study, the data collection, analysis or interpretation of data or the writing of the manuscript.