Clinical trial NCT01698840: Effect of Vitamin D in Diets of Preterm Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature Infants
Keywords: Vitamin D
Transitional Formula
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
name: The Children's Nutrition Research Center
First posted: 2012-10-03
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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.)

Primary outcomes:
measure: Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age
timeFrame: Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)
Secondary outcomes:
measure: Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age
timeFrame: Last 7 days of hospitalization and at 52 weeks PMA
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine / Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Amy h, MD
role: PRINCIPAL_INVESTIGATOR
References: