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ACTIVE NOT RECRUITING
NCT05615311
PHASE1/PHASE2

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Day - 4 Days

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2023-03-16

Completion Date

2026-05

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States