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Early Vitamin D Supplementation in Infants Born Extremely Preterm and Fed Human Milk: A Randomized Controlled Trial
Ariel A Salas1, Tori Argent1, Seabrook Jeffcoat1
1Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
Insights
Vitamin D supplementation for extremely preterm infants did not reduce bronchopulmonary dysplasia (BPD) severity but showed a trend toward improved bone health. Further research is needed to confirm these findings in high-risk neonates.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Nutritional Science
Background:
- Extremely preterm infants (born ≤28 weeks gestation) fed human milk are at high risk for respiratory complications.
- Vitamin D is crucial for bone health and immune function, but optimal supplementation for this vulnerable population is debated.
- Previous studies have yielded inconsistent results regarding vitamin D's impact on neonatal outcomes.
Purpose of the Study:
- To investigate the effect of daily vitamin D supplementation on short-term respiratory outcomes in extremely preterm infants.
- To assess the impact of vitamin D on the severity of bronchopulmonary dysplasia (BPD) and lung function.
- To evaluate vitamin D's influence on metabolic bone disease and overall bone health in this cohort.
Main Methods:
- A masked, randomized controlled trial involving 126 extremely preterm infants fed human milk.
- Infants received either 800 IU/day of vitamin D or a placebo for the first 14 days of life.
- Primary outcome: BPD severity at 36 weeks postmenstrual age. Secondary outcomes: lung function (impulse oscillometry) and metabolic bone disease markers.
Main Results:
- Vitamin D supplementation significantly increased 25-hydroxy vitamin D3 concentrations.
- No significant difference in BPD severity or lung function measurements (reactance, resistance) between groups.
- A non-statistically significant trend towards a lower risk of metabolic bone disease in the vitamin D group (9% vs. 20%).
Conclusions:
- Early-life vitamin D supplementation (800 IU/day for 14 days) did not reduce BPD severity in extremely preterm infants.
- The supplementation may offer potential benefits for bone health, warranting further investigation.
- No serious adverse events were associated with the vitamin D intervention.
Objective:
To evaluate the effects of vitamin D supplementation on short-term respiratory outcomes in infants born at 28 weeks of gestation or less and fed human milk.
Study Design:
This masked, randomized controlled trial included infants born extremely preterm and fed human milk in 2023-2024. Infants received either 800 IU/day vitamin D (intervention) or no additional vitamin D (control) for the first 14 days. Masking was maintained by adding 800 IU of vitamin D to daily feedings. The primary outcome was severity of bronchopulmonary dysplasia (BPD) at 36 weeks of postmenstrual age. Secondary outcomes included reactance and resistance (R7-19) measurements, obtained using impulse oscillometry at 36 weeks postmenstrual age, and metabolic bone disease (alkaline phosphatase >500 IU/L and phosphorus <5.5 mg/dL) at postnatal day 28.
Results:
A total of 126 infants were randomized (mean birthweight: 759 ± 228 g; 52% female). The intervention increased 25-hydroxy vitamin D3 concentrations (mean difference: +29 ng/mL; P < .0001). The severity of BPD did not differ between groups (P = .60). area under the reactance curve measurements were comparable (674 ± 207 vs 694 ± 240; P = .64) and R7-19 measurements were not significantly lower in the intervention group (23 ± 8 vs 25 ± 9; P = .18). On postnatal day 28, the lower risk of metabolic bone disease observed in the intervention group did not reach statistical significance (9% vs 20%; relative risk: 0.43; 95% CI: 0.16, 1.15; P = .08). No serious adverse events related to the intervention were reported.
Conclusions:
Administering 800 IU/day of vitamin D during the first 2 weeks did not reduce BPD severity but may contribute to improved bone health.
Trial Registration:
ClinicalTrials.gov: NCT05615311. https://clinicaltrials.gov/study/NCT05615311.
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