Completed

Supplemental Vitamin D in Transitional Formula for Preterm Infants' Bone Health

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Study Aim

This study aims to prevent bone health issues in preterm infants by evaluating the change in serum 25-hydroxyvitamin D levels at 52 weeks post-menstrual age when supplemented with Vitamin D in transitional formula.

What is being tested

Vitamin D

+ Placebo

Dietary Supplement
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on preterm infants, specifically those born between 28 and 34 weeks of gestation. These babies often receive transitional formulas, which are denser in calories than standard formulas. The main goal of this research is to understand how supplementing these formulas with different levels of Vitamin D can impact the infants' health. The study aims to ensure that no infant ends up with a Vitamin D deficiency, which is defined as having less than 20 ng/mL of a specific form of Vitamin D, called 25-hydroxyvitamin D (25-OHD), in their bloodstream at around 52 weeks post-menstrual age. During the study, infants receive transitional formula with added Vitamin D. The researchers measure the change in the infants' serum 25-OHD levels from the start of the study to approximately 52 weeks post-menstrual age. This helps them determine if the supplemented Vitamin D is effectively raising and maintaining the infants' Vitamin D levels within a healthy range. The study's primary outcome is to prevent Vitamin D deficiency in these preterm infants.

NCT01698840
Principal SponsorBaylor College of Medicine
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

7 inclusion criteria required to participate
Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130 mL/kg/day total feeding volume
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
Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight
Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals or transferred within 48 hours of birth
Show More Criteria
4 exclusion criteria prevent from participating
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
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.)
Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding intolerance

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Baylor College of Medicine / Texas Children's Hospital

Houston, United StatesOpen Baylor College of Medicine / Texas Children's Hospital in Google Maps
CompletedOne Study Center