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Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial.

Journal of the Academy of Nutrition and Dietetics
January 1, 2023
Natalia Aristizabal et al. (6 authors)
Randomized Controlled TrialJournal ArticleResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

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.

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
InfantInfant, NewbornMaleHumansFemaleInfant, Extremely PrematureBronchopulmonary DysplasiaCritical IllnessCalciumDietary SupplementsVitaminsVitamin D DeficiencyCholecalciferolDouble-Blind Method
Study Links
Quality Scores
Safety90
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations7
Citations/Year3.5
Relative Citation Ratio2.49
NIH Percentile80.7%
Research Impact Scores
APT Score0.75
Weight Score2.85
Normalized Score0.83
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