Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
NCT ID: NCT05615311
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
126 participants
INTERVENTIONAL
2023-03-16
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D group
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.
Control group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Terminal illness in whom decisions to withhold or limit life support have been made
1 Day
4 Days
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Ariel A. Salas
Associate Professor
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Salas AA, Argent T, Jeffcoat S, Tucker M, Ashraf AP, Travers CP. Early Vitamin D Supplementation in Infants Born Extremely Preterm and Fed Human Milk: A Randomized Controlled Trial. J Pediatr. 2025 Jul 24;287:114754. doi: 10.1016/j.jpeds.2025.114754. Online ahead of print.
Other Identifiers
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300010307
Identifier Type: -
Identifier Source: org_study_id
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