Prematurity; ExtremePhase 1/2NCT05615311
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
A Phase 1/2 study testing Vitamin D supplementation and No additional vitamin D supplementation in people with Prematurity; Extreme, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- Vitamin D supplementation and No additional vitamin D supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age of 28 weeks or less
Who cannot join
- Major congenital anomalies and infants
- Terminal illness in whom decisions to withhold or limit life support have been made
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
- Conditions
- Prematurity; Extreme
- Being tested
- Vitamin D supplementation, No additional vitamin D supplementation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationDietary supplement
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 supplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Not described Receives: Dietary Supplement: Vitamin D supplementation |
| Control group | Placebo comparator | Not described Receives: Other: No additional vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 40 - 120 days
Secondary outcomes (1)
Bronchopulmonary dysplasia
Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge
Measured: 36 weeks PMA or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start16 Mar 2023
- Primary completion17 Oct 2024
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615311
- Sponsor's protocol ID
- IRB-300010307
- Other IDs
- KPRI Award
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40714046
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05615311
- Acronym / sponsor ID
- IRB-300010307
- Conditions
- Prematurity; Extreme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Dietary Supplement: Vitamin D supplementation |
| Control group | Placebo comparator | Other: No additional vitamin D supplementation |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age of 28 weeks or less
Key exclusion criteria (2 listed)
- Major congenital anomalies and infants
- Terminal illness in whom decisions to withhold or limit life support have been made
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementationStudy 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. | Dietary supplement | Vitamin D group |
| No additional vitamin D supplementationStudy 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. | Other | Control group |
Primary outcome
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
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)
1 secondary outcome
Bronchopulmonary dysplasia
Time frame: 36 weeks PMA or discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 40714046Salas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D supplementation and No additional vitamin D supplementation in people with Prematurity; Extreme, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of respiratory morbidity (time frame: 0 - 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.