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

June 4, 2026 updated by: Ariel A. Salas, University of Alabama at Birmingham

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 days (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestational age of 28 weeks or less

Exclusion Criteria:

  • Major congenital anomalies and infants
  • Terminal illness in whom decisions to withhold or limit life support have been made

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
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.
Experimental: Vitamin D group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of respiratory morbidity
Time Frame: 0 - 120 days
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
Time Frame: 40 - 120 days
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
40 - 120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchopulmonary dysplasia
Time Frame: 36 weeks PMA or discharge
Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge
36 weeks PMA or discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

October 17, 2024

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300010307
  • KPRI Award (Other Identifier: UAB Department of Pediatrics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity; Extreme

Clinical Trials on Vitamin D supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe