NCT05615311

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 4 Days
• Healthy volunteers: Not accepted

Summary

This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.

Conditions

• Prematurity; Extreme

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D supplementation	Study participants assigned to the intervention group will receive 800 IU/ day of vitamin D plus 200-300 IU/day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.
OTHER	No additional vitamin D supplementation	Study participants assigned to the control group will receive 200-300 IU/ day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.

Timeline

• Start date: 2023-03-16
• Primary completion: 2024-10-17
• Completion: 2026-05-01
• First posted: 2022-11-14
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States