Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
1 other identifier
interventional
126
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedStudy Start
First participant enrolled
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMay 30, 2025
May 1, 2025
1.6 years
November 3, 2022
May 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Severity of respiratory morbidity
A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen
0 - 120 days
Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
40 - 120 days
Secondary Outcomes (1)
Bronchopulmonary dysplasia
36 weeks PMA or discharge
Study Arms (2)
Vitamin D group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
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.
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
You may qualify if:
- Gestational age of 28 weeks or less
You may not qualify if:
- Major congenital anomalies and infants
- Terminal illness in whom decisions to withhold or limit life support have been made
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Related Publications (1)
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 Dec;287:114754. doi: 10.1016/j.jpeds.2025.114754. Epub 2025 Jul 24.
PMID: 40714046DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 14, 2022
Study Start
March 16, 2023
Primary Completion
October 17, 2024
Study Completion
May 1, 2026
Last Updated
May 30, 2025
Record last verified: 2025-05