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Randomized Controlled Trial of Enteral Vitamin D Supplementation (ViDES) in Infants <28 Weeks Gestational Age or
Mar Romero-Lopez1, Jon E Tyson1, Mamta Naik2
1The University of Texas Health Science Center at Houston.
Insights
This study compares two vitamin D supplementation regimens for extremely preterm infants. Higher doses may improve vitamin D levels and reduce respiratory support, aiding infant development.
Area of Science:
- Neonatology
- Pediatric Nutrition
- Endocrinology
Background:
- Vitamin D is crucial for infant organ development, particularly lungs.
- Extremely preterm infants (<28 weeks gestation) often have low vitamin D at birth and limited intake.
- Current vitamin D supplementation guidelines for these infants are debated, with unclear effects on outcomes.
Purpose of the Study:
- To compare the effectiveness of two enteral vitamin D supplementation regimens in extremely preterm infants.
- To determine if higher early vitamin D doses increase serum 25-hydroxyvitamin D3 levels and improve respiratory outcomes.
- To evaluate the impact of different regimens on neurodevelopmental outcomes up to 2 years corrected age.
Main Methods:
- A randomized, blinded comparative effectiveness trial involving infants <28 weeks gestation or <1000g birth weight.
- Infants received either routine (400 IU/day) or increased (800 IU/day) vitamin D supplementation for the first 28 days.
- Outcomes measured include serum 25-hydroxyvitamin D3 levels, respiratory support needs, and neurodevelopmental assessments.
Main Results:
- The study hypothesizes that the 800 IU/day regimen will significantly increase vitamin D levels compared to the 400 IU/day regimen.
- The higher dose is also predicted to reduce the need for respiratory support at 36 weeks postmenstrual age.
- Bayesian analyses provide high power to detect these anticipated differences.
Conclusions:
- This trial aims to 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 grams birth weight at a large academic center in the United States.Infants are stratified by birth weight and randomized within 96 hours 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/d with early feeding) compared to placebo plus routine dose (400 IU/d with established feeding) will substantially increase total 25-hydroxyvitamin D3 levels measured as state-of-art at one 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 preterminfants. 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 registered on July 14, 2022 (NCT05459298).
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