Objective
To determine the optimal dose of vitamin D supplementation to achieve biochemical vitamin D sufficiency in extremely low gestational age newborns in a masked randomized controlled trial.
Study design
100 infants 23 0/7 to 27 6/7 weeks gestation were randomized to vitamin D intakes of placebo (n=36), 200 IU (n=34), and 800 IU/day (n=30) (approximating 200, 400, or 1000 IU/day, respectively, when vitamin D routinely included in parenteral or enteral nutrition is included). The primary outcomes were serum 25 (OH) vitamin D concentrations on postnatal day 28 and the number of days alive and off respiratory support in the first 28 days.
Results
At birth, 67% of infants had 25(OH) vitamin D < 20 ng/mL suggesting biochemical vitamin D deficiency. Vitamin D concentrations on day 28 were (Median [25th–75th centiles], ng/mL): Placebo: 22 [13–47], 200 IU: 39 [26–57], 800 IU: 84.5 [52–99], p < 0.001. There were no differences in days alive and off respiratory support (Median (25th–75th centiles), days: Placebo: 1 (0–11), 200 IU: 0 (0–8), 800 IU: 0.5 (0–22), p=0.63), or other respiratory outcomes among groups.
Conclusion
At birth, most extremely preterm infants have biochemical vitamin D deficiency. This biochemical deficiency is reduced on day 28 by supplementation with 200 IU/day and prevented by 800 IU/day. Larger trials are required to determine if resolution of biochemical vitamin D deficiency improves clinical outcomes. ClinicalTrials.gov: NCT01600430
Trial registration
ClinicalTrials.gov: NCT01600430