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Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or
Mar Romero-Lopez1,2, Jon E Tyson3,4, Mamta Naik5
1Division of Perinatal-Neonatal Medicine, Department of Pediatrics, University of Texas Health Science Center Houston, McGovern Medical School, 6431 Fannin St, Houston, TX, 77030, USA. maria.del.mar.romerolopez@uth.tmc.edu.
Insights
This study investigates vitamin D supplementation for extremely preterm infants. Higher doses may improve lung function and neurodevelopmental outcomes, guiding future treatment guidelines.
Area of Science:
- Neonatal Medicine
- Pediatric Nutrition
- Clinical Trial Research
Background:
- Vitamin D is crucial for infant organ development, yet extremely preterm infants often have low levels at birth.
- Current vitamin D supplementation protocols for these infants are debated, with unclear impacts on outcomes.
- Enteral vitamin D is a cost-effective intervention, necessitating optimized dosing strategies.
Purpose of the Study:
- To compare two vitamin D supplementation regimens in extremely preterm infants (<28 weeks gestation or <1000g birth weight).
- To determine if higher early vitamin D doses (800 IU/day) improve serum 25-hydroxyvitamin D3 levels, reduce respiratory support, and enhance neurodevelopmental outcomes compared to routine doses (400 IU/day).
Main Methods:
- A randomized, blinded comparative effectiveness trial involving infants <28 weeks gestation or <1000g birth weight.
- Infants received either 400 IU/day (routine) or 800 IU/day (increased) of vitamin D for the first 28 days.
- Outcomes assessed include serum 25-hydroxyvitamin D3 levels at 1 month, respiratory support at 36 weeks postmenstrual age, and neurodevelopment at 22-26 months corrected age.
Main Results:
- Hypothesizes that the 800 IU/day regimen will significantly increase 25-hydroxyvitamin D3 levels.
- Anticipates a reduction in respiratory support needs at 36 weeks postmenstrual age with the higher dose.
- Aims to demonstrate improved or non-worsened secondary clinical outcomes and neurodevelopmental assessments.
Conclusions:
- This trial will clarify the relationship between vitamin D supplementation and clinical outcomes in extremely preterm infants.
- Findings could lead to revised supplementation guidelines for this vulnerable population.
- Results may support a larger multicenter study to confirm generalizability.
Background:
Vitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks' gestation have low vitamin D levels at birth and a limited intake during the first month. Enteral vitamin D supplementation is inexpensive and widely used. The appropriate supplementation regimen for extremely preterm infants is controversial, and the effect of different regimens on their blood levels and outcomes is unclear.
Methods:
Randomized, blinded comparative effectiveness trial to compare two vitamin D supplementation regimens for inborn infants <28 weeks gestation or <1000 g birth weight at a large academic center in the United States. Infants are stratified by birth weight and randomized within 96 h after birth to either routine supplementation (400 IU/day with established feedings) or increased supplementation (800 IU/day with any feedings) during the first 28 days after birth. We hypothesize that the higher and early vitamin D dose (800 IU/day with early feeding) compared to placebo plus routine dose (400 IU/day with established feeding) will substantially increase total 25-hydroxyvitamin D3 levels measured as state-of-art at 1 month, reduce respiratory support at 36 weeks' postmenstrual age (on an ordinal scale predictive of later adverse outcomes), and improve or at least not worsen other important secondary outcomes. The infants in the study will follow up at 22-26 months' corrected age (~2 years) with blinded certified examiners to evaluate neurodevelopmental outcomes. The sample size of a minimum of 180 infants provides >90% power to detect a >95% posterior probability of a 33% increase in serum 25-hydroxy vitamin D3 and >80% power to detect a >80% posterior probability of a relative risk decrease of 20% of reducing respiratory support by intention-to-treat Bayesian analyses using a neutral prior probability.
Discussion:
Our study will help clarify the uncertain relationship of vitamin D supplementation and its associated serum metabolites to clinical outcomes of extremely preterm infants. Confirmation of our hypotheses would prompt reconsideration of the supplementation regimens used in extremely preterm infants and justify a large multicenter study to verify the generalizability of the results.
Trial Registration:
ClinicalTrials.gov NCT05459298. Registered on July 14, 2022.
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