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NCT05615311 · ClinicalTrials.gov registry record · Phase 1
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
A Phase 1 study of Prematurity; Extreme, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT05615311: Active Phase 1 study of Prematurity; Extreme, sponsored by University of Alabama at Birmingham.
NCT05615311 is a Phase 1 study of Prematurity; Extreme that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 126 participants, below the 216-participant average among 4 other Prematurity; Extreme trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05615311, a Phase 1 study of Prematurity; Extreme, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D supplementation
- OTHER No additional vitamin D supplementation
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What the registry record for NCT05615311 still lists
NCT05615311 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 216-participant average among 4 other Prematurity; Extreme trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Prematurity; Extreme appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D supplementation is the first listed.
NCT05615311 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05615311 about?
NCT05615311 is a clinical study titled "Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm". 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.
What is the current status of trial NCT05615311?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2023-03-16. Estimated completion is 2026-05.
What conditions does trial NCT05615311 study?
This clinical trial studies the following conditions: Prematurity; Extreme.
What interventions are being tested in trial NCT05615311?
The interventions under investigation include: Vitamin D supplementation (DIETARY_SUPPLEMENT), No additional vitamin D supplementation (OTHER).
Who is sponsoring clinical trial NCT05615311?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05615311 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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