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Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Sponsor: The University of Texas Health Science Center, Houston
Summary
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
Key Details
Gender
All
Age Range
24 Hours - 96 Hours
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-02-15
Completion Date
2029-06-01
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.
Usual Care
Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices
Locations (1)
The University of Texas Medical Branch
Galveston, Texas, United States