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

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 D-3 (n=60 in each group). Primary outcome was prevalence of vitamin D insufficiency (serum vitamin D levels < 29 ng ml(-1)) at 40 weeks of corrected gestational age (CGA). RESULTS: At term CGA vitamin 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 D-3 daily decreases the prevalence of vitamin D insufficiency at term CGA. Excess levels of vitamin D may occur at this dose in some babies.