Loading clinical trials...

Effect of Vitamin D in Diets of Preterm Infants | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT01698840•Baylor College of Medicine

View on ClinicalTrials.gov

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).

Eligibility

Age

All ages

Sex

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.)

Locations (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

July 30, 2016

Completion Date

July 30, 2016

Last Updated

January 29, 2026

Enrollment

ACTUAL participants

Conditions

Premature Infants

Interventions

Vitamin D

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants

NCT07322731

Premature InfantsSleep Quality+4 more

View study

ENROLLING_BY_INVITATIONNA

The Video System to Provide a Developmental Training Guide for Preterm Infants

NCT06965842

Premature InfantsVery Low Birth Weight Infants

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect of Vitamin D in Diets of Preterm Infants

Inclusion Criteria

Exclusion Criteria

The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants

The Video System to Provide a Developmental Training Guide for Preterm Infants

Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home

Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes

Maternal Oral Therapy to Reduce Obstetric Risk Kids