Effect of Vitamin D in Diets of Preterm Infants
This trial is active, not recruiting.
|Treatments||vitamin d, placebo|
|Sponsor||Baylor College of Medicine|
|Collaborator||USDA Beltsville Human Nutrition Research Center|
|Start date||January 2013|
|End date||July 2016|
|Trial size||39 participants|
|Trial identifier||NCT01698840, H-31433|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age
time frame: Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)
Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age
time frame: Last 7 days of hospitalization and at 52 weeks PMA
Male or female participants of any age.
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.)
|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|
|Principal investigator||Amy h, MD|
Call for more information