Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial.
Study Goal
The researchers aimed to determine the safety and efficacy of enteral vitamin D supplementation in extremely preterm infants, focusing on calcium-related outcomes and vitamin D deficiency correction.
Results Summary
The study found that 800 IU/day of vitamin D safely corrected vitamin D deficiency by Postnatal Day 14, with no observed calcium or vitamin D toxicity. The predictive risk of severe bronchopulmonary dysplasia was lower in the 200 IU and 800 IU groups, though not statistically significant.
Population
Extremely preterm infants (≤28 weeks' gestation) in a southern US academic neonatal unit, with 56% Black and 44% White infants.
Effective Dosage
200 IU/day or 800 IU/day of vitamin D, compared to placebo.
Duration
28 days after birth.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
placebo | increase | serum 25-hydroxy vitamin D (25[OH]D) concentration | infants born extremely preterm | +9 ng/mL | mean difference in 25(OH)D was +9 | #1 |
200 IU/day vitamin D | increase | serum 25-hydroxy vitamin D (25[OH]D) concentration | infants born extremely preterm | +23 ng/mL | mean difference in 25(OH)D was +23 | #2 |
800 IU/day vitamin D | increase | serum 25-hydroxy vitamin D (25[OH]D) concentration | infants born extremely preterm | +62 ng/mL | mean difference in 25(OH)D was +62 | #3 |
vitamin D supplementation | increase | serum 25-hydroxy vitamin D (25[OH]D) concentration | Black infants | - | increase observed in 25(OH)D was more significant | #4 |
200 IU/day vitamin D | decrease | predictive risk of severe bronchopulmonary dysplasia | infants born extremely preterm | - | predictive risk of severe bronchopulmonary dysplasia was lower | #5 |
800 IU/day vitamin D | decrease | predictive risk of severe bronchopulmonary dysplasia | infants born extremely preterm | - | predictive risk of severe bronchopulmonary dysplasia was lower | #6 |
vitamin D supplementation | no change | vitamin D toxicity | infants born extremely preterm | no toxicity | no vitamin D toxicity was observed | #7 |
vitamin D supplementation | no change | calcium toxicity | infants born extremely preterm | no toxicity | no calcium toxicity was observed | #8 |
800 IU/day vitamin D | decrease | vitamin D deficiency | infants born extremely preterm | - | safely corrected vitamin D deficiency by Postnatal Day 14 | #9 |
BACKGROUND: Despite substantial evidence that vitamin D deficiency is highly prevalent among infants born extremely preterm (≤28 weeks' of gestation), several consensus statements do not recommend vitamin D doses >400 IU/day for these infants. Safety remains a concern. OBJECTIVE: The study aim was to determine safety and efficacy profiles of enteral vitamin D in Black and White infants randomized to three different vitamin D doses soon after birth. DESIGN: Ancillary study of a masked randomized clinical trial. PARTICIPANTS/SETTING: Seventy-three infants born extremely preterm between 2012 and 2015 at a southern US academic neonatal unit (33' latitude) who had >90% compliance with the assigned intervention were included. INTERVENTION: Infants were randomized to receive placebo (placebo group), 200 IU/day vitamin D (200 IU group), or 800 IU/day vitamin D (800 IU group) during the first 28 days after birth. MAIN OUTCOME MEASURES: Safety outcomes included serum 25-hydroxy vitamin D (25[OH]D) and calcium concentrations. Efficacy outcomes included the predictive risk of bronchopulmonary dysplasia. STATISTICAL ANALYSIS: Per-protocol analysis using unadjusted, repeated-measures mixed models. RESULTS: Mean birth weight was 815 ± 199 g. Half were male and 56% were Black. Of 58 infants with 25(OH)D measurements at birth, 40 (69%) had vitamin D deficiency (<20 ng/mL). The mean difference in 25(OH)D in nanograms per milliliter between Postnatal Day 28 and Postnatal Day 1 was +9 in the placebo group, +23 in the 200 IU group, and +62 in the 800 IU group (P < 0.0001). The increase observed in 25(OH)D was more significant among Black infants. The predictive risk of severe bronchopulmonary dysplasia in the 200 IU and 800 IU groups was lower, but this difference did not reach statistical significance. No vitamin D or calcium toxicity was observed. CONCLUSIONS: A vitamin D dose of 800 IU/day safely corrected vitamin D deficiency by Postnatal Day 14.