NEODOSE

INDICATIONS

• Prevention and treatment of vitamin D deficiency: For breastfed infants, the AAP recommends that supplementation should begin within the first few days of life, regardless of whether the infant is exclusively breastfed or supplemented with infant formula. Exclusively formula-fed infants receiving at least 1000 mL/day of formula receive adequate amounts of vitamin D without supplementation
• Dose comparison: Median vitamin D concentrations were 22 ng/mL for placebo, 39 ng/mL for 200 international units, and 85 ng/mL for 800 international units (p less than 0.05) of oral vitamin D supplementation for 28 days in 100 newborns (23 to 27 weeks of gestation; mean weight 770 g) in a randomized, double-blinded, placebo-controlled trial. The mean number of days alive and off respiratory support at day 28 were 6.8 +/- 9.5 for placebo, 5.5 +/- 9.1 for 200 international units, and 7 +/- 10.3 for 800 international units (p=0.78). At 2 years of age, cognitive scores, neurodevelopment, language, and respiratory outcomes were not different between vitamin D and placebo (n=70). Although underpowered, 800 international units of vitamin D did not result in improvement in any outcomes at 2 years of age compared with 200 international units or placebo. Some data indicate that administration of high doses of vitamin D (4000 to 6400 international units daily) to breastfeeding mothers is capable of raising 25(OH)-D levels in the infant to levels similar to those seen with infant supplementation without causing hypervitaminosis D in the mother. Fortified mature human milk (24 kcal/oz) provides 283 to 379 international units/day, preterm formulas (24 kcal/oz) provide 290 to 468 international units/day, and transitional formula (22 kcal/oz) provides 125 to 127 international units/day of vitamin D in neonates (weighing more than 1500 g) with intakes of 160 mL/kg/day.
• Rickets: In enterally fed preterm infants with radiologic evidence of rickets, maximize nutrient intake by increasing human milk fortifier and/or volume of preterm formula. If maximization cannot be tolerated, then supplementation with elemental calcium and phosphorus is recommended. Vitamin D status should be evaluated and target 25- hydroxyvitamin D concentrations of greater than 20 ng/mL (50 nmol/L)

CONTRAINDICATIONS/PRECAUTIONS

Most liquid preparations contain propylene glycol.

ADVERSE EFFECTS

Signs of vitamin D toxicity include hypercalcemia, azotemia, vomiting, and nephrocalcinosis. A 25(OH)-D concentration greater than 250 nmol/L may be associated with a risk for vitamin D intoxication.

MONITORING

Signs of vitamin D deficiency include symptomatic hypocalcemia (including seizures), growth failure, irritability, lethargy, and increased susceptibility for respiratory infections. A 25- hydroxyvitamin D (25(OH)-D) concentration of less than 50 nmol/L is thought to be indicative of vitamin D deficiency in infants . Biochemical monitoring of bone mineral content should be performed in very low birth weight (less than 1500 g) infants starting 4 to 5 weeks after birth.