Overview

This trial is active, not recruiting.

Condition premature infants
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

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Investigational Nutrition group will receive vitamin D drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
vitamin d
(Placebo Comparator)
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Routine Nutrition group will receive placebo drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
placebo

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
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

Eligibility Criteria

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.)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.