A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates

J Perinatol. 2016 Sep;36(9):763-7. doi: 10.1038/jp.2016.70. Epub 2016 May 5.

Abstract

Objective: To compare the efficacy of 400 vs 1000 IU oral vitamin D supplementation in preterm neonates of 27 to 34 weeks gestation.

Methods: This double-blind randomized controlled trial allocated preterm babies to receive either 400 or 1000 IU of vitamin D3 (n=60 in each group). Primary outcome was prevalence of vitamin D insufficiency (serum vitamin D levels<20 ng ml(-1)) at 40 weeks of corrected gestational age (CGA).

Results: At term CGA vitamin D insufficiency was significantly lower in the 1000 IU group than in the 400 IU group (2% vs 64.6%, P⩽0.001). Although elevated vitamin D levels were seen in 9.8% of babies on 1000 IU per day, this was not associated with clinical or biochemical evidence of toxicity.

Conclusion: Supplementing preterm babies with 1000 IU of vitamin D3 daily decreases the prevalence of vitamin D insufficiency at term CGA. Excess levels of vitamin D may occur at this dose in some babies.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Calcium / blood
  • Cholecalciferol / administration & dosage*
  • Cholecalciferol / blood
  • Dietary Supplements
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gestational Age
  • Humans
  • India
  • Infant, Newborn
  • Male
  • Tertiary Care Centers
  • Vitamin D Deficiency / blood
  • Vitamin D Deficiency / drug therapy*

Substances

  • Cholecalciferol
  • Calcium