A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates

Area of Science:

• Neonatal Medicine
• Pediatric Endocrinology
• Nutritional Science

Background:

• Preterm neonates are at high risk for vitamin D deficiency due to limited fetal stores and reduced postnatal intake.
• Vitamin D insufficiency can negatively impact bone health, immune function, and overall development in preterm infants.

Purpose of the Study:

• To compare the efficacy of 400 IU versus 1000 IU of oral vitamin D supplementation in preterm neonates.
• To determine the optimal vitamin D dosage for preterm infants to prevent insufficiency at term corrected gestational age.

Main Methods:

• A double-blind, randomized controlled trial was conducted with preterm infants (27-34 weeks gestation).
• Infants were allocated to receive either 400 IU or 1000 IU of vitamin D3 daily.
• The primary outcome was the prevalence of vitamin D insufficiency (serum levels < 20 ng/mL) at 40 weeks of corrected gestational age (CGA).

Main Results:

• Vitamin D insufficiency was significantly lower in the 1000 IU group (2%) compared to the 400 IU group (64.6%) at term CGA (P≤0.001).
• Elevated vitamin D levels were observed in 9.8% of infants receiving 1000 IU daily.
• No clinical or biochemical evidence of vitamin D toxicity was associated with the elevated levels.

Conclusions:

• Daily supplementation with 1000 IU of vitamin D3 effectively decreases vitamin D insufficiency in preterm infants by term CGA.
• While higher doses are more effective, monitoring for potential excess vitamin D levels is advisable in some infants.