Effect of Vitamin D in Diets of Preterm Infants

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698840

Enrollment

Registered

2012-10-03

Start date

2013-01-01

Completion date

2016-07-30

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infants

Keywords

Vitamin D, Transitional Formula

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).

Interventions

DIETARY_SUPPLEMENTVitamin D

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age	Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)

Secondary

Measure	Time frame
Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age	Last 7 days of hospitalization and at 52 weeks PMA

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAmy h, MD

Baylor College of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026