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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 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.

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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.

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

FieldValue
Enrollment Target 126 participants
Start Date 2023-03-16
Est. Completion 2026-05
Phase Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT05615311

The ClinicalTrials.gov registry entry for NCT05615311 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 216-participant average among 4 other Prematurity; Extreme trials with a reported enrollment target (42% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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