Effect of Vitamin D in Diets of Preterm Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/23/2019 |
| Start Date: | January 2013 |
| End Date: | January 2017 |
An Evaluation of the Effects of Two Levels of Vitamin D in Infants Fed Preterm or Transitional Formula on Serum 25-Hydroxyvitamin D and Bone Status in Preterm Infants: A Double-Blind, Randomized Controlled Trial
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).
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.)
We found this trial at
1
site
Houston, Texas
Principal Investigator: Amy Hair, MD
Phone: 832-826-3719
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