NCT05694689

Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 24 Hours – 96 Hours
• Healthy volunteers: Not accepted

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).

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
OTHER	Usual Care	Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices

Timeline

• Start date: 2023-02-15
• Primary completion: 2026-01-01
• Completion: 2029-06-01
• First posted: 2023-01-23
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States