Bronchopulmonary Dysplasia (BPD)Phase 3VITA-BPDNCT07577180
Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants
A Phase 3 study testing Vitamin A in people with Bronchopulmonary Dysplasia (BPD) and Prematurity, run by Erhan Calisici at 1 site in Turkey (Türkiye).
Trial summary
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an increased risk of BPD. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
- What is being tested?
- Vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2012to 1 Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants with gestational age ≤32 weeks
- Birth weight ≤1250 grams
- Admitted to the neonatal intensive care unit
- Initiated enteral feeding within the first days of life
Who cannot join
- Major congenital anomalies
- Chromosomal abnormalities
- Severe perinatal asphyxia
- Inborn errors of metabolism
- Infants who died before initiation of enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weekly High-Dose Oral Vitamin A Supplementation on Bronchopulmonary Dysplasia in Very Low Birth Weight Preterm Infants: A Randomized Controlled Trial
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an increased risk of BPD.
This study aimed to evaluate the effect of prophylactic oral high-dose vitamin A supplementation on the incidence of BPD in preterm infants with a gestational age ≤32 weeks and birth weight <1250 g.
Read more
In this randomized controlled trial, preterm infants were assigned to receive either oral vitamin A supplementation or standard care. The primary outcome was the development of BPD. Secondary outcomes included mortality and other neonatal morbidities.
The findings of this study may provide evidence regarding the effectiveness of oral vitamin A supplementation as a simple and accessible strategy to reduce the risk of BPD in preterm infants.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is a chronic lung disease commonly observed in very low birth weight (VLBW) preterm infants and is associated with significant morbidity and mortality. Vitamin A plays a critical role in lung growth, epithelial differentiation, and repair processes. Previous studies have suggested that vitamin A supplementation may reduce the incidence of BPD, although the optimal route and regimen remain uncertain.
This study was designed as a randomized controlled trial to assess the efficacy of oral high-dose vitamin A supplementation in preventing BPD in preterm infants. Infants with a gestational age of ≤32 weeks and birth weight <1250 g were enrolled and randomly assigned to receive either prophylactic oral vitamin A supplementation or standard neonatal care.
The primary outcome was the incidence of BPD, defined according to standard clinical criteria. Secondary outcomes included mortality, duration of respiratory support, and other neonatal complications.
The results of this study may contribute to the existing evidence on vitamin A supplementation and support the development of accessible and non-invasive preventive strategies for BPD in preterm infants.
- Being tested
- Vitamin A
- Keywords
- Vitamin A, Preterm Infants, Bronchopulmonary Dysplasia, Randomized Controlled Trial, Neonatal Intensive Care
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
Also called Retinol
Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A Group | Experimental | Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care. Receives: Drug: Vitamin A |
| Control Group | No intervention | Preterm infants received standard neonatal care without vitamin A supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary Dysplasia
Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.
Measured: At 36 weeks postmenstrual age
Mortality
All-cause mortality during hospitalization.
Measured: Up to 44 weeks postmenstrual age
Secondary outcomes (4)
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation in days.
Measured: Up to 44 weeks postmenstrual age
Length of Hospital Stay
Total duration of hospitalization from birth to discharge in days.
Measured: Up to 44 weeks postmenstrual age
Necrotizing Enterocolitis
Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.
Measured: Up to 44 weeks postmenstrual age
Retinopathy of Prematurity
Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.
Measured: Up to 44 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Mar 2012
- Primary completion1 Mar 2013
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel groups: oral vitamin A supplementation or standard care.
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erhan Calisici
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Erhan Calisici, Kocaeli City Hospital
- Investigators
- Erhan Calisici, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577180
- Sponsor's protocol ID
- VITA-BPD-2012
- Acronym
- VITA-BPD
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional and ethical restrictions, including patient confidentiality and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weekly High-Dose Oral Vitamin A Supplementation on Bronchopulmonary Dysplasia in Very Low Birth Weight Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07577180
- Acronym / sponsor ID
- VITA-BPD / VITA-BPD-2012
- Keywords
- Vitamin A, Preterm Infants, Bronchopulmonary Dysplasia, Randomized Controlled Trial, Neonatal Intensive Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Erhan CalisiciOther government
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 11 May 2026 (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.
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an increased risk of BPD.
This study aimed to evaluate the effect of prophylactic oral high-dose vitamin A supplementation on the incidence of BPD in preterm infants with a gestational age ≤32 weeks and birth weight <1250 g.
In this randomized controlled trial, preterm infants were assigned to receive either oral vitamin A supplementation or standard care. The primary outcome was the development of BPD. Secondary outcomes included mortality and other neonatal morbidities.
The findings of this study may provide evidence regarding the effectiveness of oral vitamin A supplementation as a simple and accessible strategy to reduce the risk of BPD in preterm infants.
Detailed description
Bronchopulmonary dysplasia (BPD) is a chronic lung disease commonly observed in very low birth weight (VLBW) preterm infants and is associated with significant morbidity and mortality. Vitamin A plays a critical role in lung growth, epithelial differentiation, and repair processes. Previous studies have suggested that vitamin A supplementation may reduce the incidence of BPD, although the optimal route and regimen remain uncertain.
This study was designed as a randomized controlled trial to assess the efficacy of oral high-dose vitamin A supplementation in preventing BPD in preterm infants. Infants with a gestational age of ≤32 weeks and birth weight <1250 g were enrolled and randomly assigned to receive either prophylactic oral vitamin A supplementation or standard neonatal care.
The primary outcome was the incidence of BPD, defined according to standard clinical criteria. Secondary outcomes included mortality, duration of respiratory support, and other neonatal complications.
The results of this study may contribute to the existing evidence on vitamin A supplementation and support the development of accessible and non-invasive preventive strategies for BPD in preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups: oral vitamin A supplementation or standard care.
| Arm | Type | Receives |
|---|---|---|
| Vitamin A Group | Experimental | Drug: Vitamin APreterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care. |
| Control Group | No intervention | –Preterm infants received standard neonatal care without vitamin A supplementation. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preterm infants with gestational age ≤32 weeks
- Birth weight ≤1250 grams
- Admitted to the neonatal intensive care unit
- Initiated enteral feeding within the first days of life
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Chromosomal abnormalities
- Severe perinatal asphyxia
- Inborn errors of metabolism
- Infants who died before initiation of enteral feeding
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 AAlso: RetinolOral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia. | Drug | Vitamin A Group |
Primary outcome
Bronchopulmonary Dysplasia
Time frame: At 36 weeks postmenstrual age
Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.
Mortality
Time frame: Up to 44 weeks postmenstrual age
All-cause mortality during hospitalization.
4 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Up to 44 weeks postmenstrual age
Length of Hospital Stay
Time frame: Up to 44 weeks postmenstrual age
Necrotizing Enterocolitis
Time frame: Up to 44 weeks postmenstrual age
Retinopathy of Prematurity
Time frame: Up to 44 weeks postmenstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional and ethical restrictions, including patient confidentiality and data protection regulations.
Related trials for Bronchopulmonary Dysplasia (BPD)
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 2/3
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
Bronchopulmonary Dysplasia
RecruitingPhase 1/2
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
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.
Erhan Calisici, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin A in people with Bronchopulmonary Dysplasia (BPD) and Prematurity, run by Erhan Calisici at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bronchopulmonary Dysplasia (time frame: At 36 weeks postmenstrual age). 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?
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 11 May 2026.