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Completed

NCT Number: NCT01698840

Effect of Vitamin D in Diets of Preterm Infants

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Vitamin D

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Mead Johnson Nutrition
  • The Children's Nutrition Research Center

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2012
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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