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 C G Doery, Ronald Tudball, Madeleine Jona, Roisin Bhamjee, Christine P. Rodda

Research output: Contribution to journalArticleResearchpeer-review

14 Citations (Scopus)

Abstract

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.

Original languageEnglish
JournalJournal of Paediatrics and Child Health
Volume53
Issue number2
DOIs
Publication statusPublished - Feb 2017

Keywords

  • 25OHD
  • Cholecalciferol
  • Infant
  • Newborn
  • Vitamin D

Cite this

Huynh, Julie ; Lu, Thao ; Liew, Danny ; Doery, James C G ; Tudball, Ronald ; Jona, Madeleine ; Bhamjee, Roisin ; Rodda, Christine P. / Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants. In: Journal of Paediatrics and Child Health. 2017 ; Vol. 53, No. 2.
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abstract = "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.",
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Vitamin D in newborns. A randomised controlled trial comparing daily and single oral bolus vitamin D in infants. / Huynh, Julie; Lu, Thao; Liew, Danny; Doery, James C G; Tudball, Ronald; Jona, Madeleine; Bhamjee, Roisin; Rodda, Christine P.

In: Journal of Paediatrics and Child Health, Vol. 53, No. 2, 02.2017.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Huynh, Julie

AU - Lu, Thao

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AU - Doery, James C G

AU - Tudball, Ronald

AU - Jona, Madeleine

AU - Bhamjee, Roisin

AU - Rodda, Christine P.

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N2 - 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.

AB - 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.

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