Effect of Vitamin D in Diets of Preterm Infants
Effect of Vitamin D in Diets of Preterm Infants
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation
 at birth. However, few data are available related to follow-up of infants receiving these
 formulas who were 28-34 weeks gestation at birth.

 Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead
 to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less
 than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
Inclusion Criteria:

 -  Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight.

 -  Currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent.

 -  Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals
 or transferred within 48 hours of birth.

 -  Care expected to be provided at one of these institutions until discharge home.

 -  Any initial feeding will be permitted, but expected to transition to primarily (80% of
 feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks PMA or
 hospital discharge, whichever comes first.

 -  Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130
 mL/kg/day total feeding volume.

 -  No longer receiving any form of mechanical ventilation or diuretics. Low flow nasal
 cannula (< ¼ LPM) will be permitted if it is anticipated this will be discontinued
 before hospital discharge.

 Exclusion Criteria:

 -  Bronchopulmonary dysplasia (BPD) requiring daily use of diuretics beyond 38 6/7 weeks
 PMA (or hospital discharge, whichever comes first) and > 22 kcal/oz concentration
 formula beyond 38 6/7 weeks PMA.

 -  Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding
 intolerance.

 -  Caloric density greater than 22 kcal/oz.

 -  Higher order multiples (However, twins are acceptable. Twins will be randomized
 together. Only data from 1 twin picked at random will be used in the final analyses.)