Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants (VITA-BPD)

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.

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Bronchopulmonary Dysplasia (BPD); Very Low Birth Weight
• Intervention / Treatment: Drug: Vitamin A

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 Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kocaeli
    • Köseköy, Kocaeli, Turkey (Türkiye), 41060
      • Kocaeli City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Major congenital anomalies
• Chromosomal abnormalities
• Severe perinatal asphyxia
• Inborn errors of metabolism
• Infants who died before initiation of enteral feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin A Group; Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care.	Drug: Vitamin A; Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.; Other Names: Retinol
No Intervention: Control Group; Preterm infants received standard neonatal care without vitamin A supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchopulmonary Dysplasia	Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.	At 36 weeks postmenstrual age
Mortality	All-cause mortality during hospitalization.	Up to 44 weeks postmenstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Mechanical Ventilation	Total duration of invasive mechanical ventilation in days.	Up to 44 weeks postmenstrual age
Length of Hospital Stay	Total duration of hospitalization from birth to discharge in days.	Up to 44 weeks postmenstrual age
Necrotizing Enterocolitis	Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.	Up to 44 weeks postmenstrual age
Retinopathy of Prematurity	Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.	Up to 44 weeks postmenstrual age

Collaborators and Investigators

• Sponsor: Erhan Calisici
• Investigators: Principal Investigator: Erhan Calisici, MD, Kocaeli City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Vitamin A; Preterm Infants; Bronchopulmonary Dysplasia; Neonatal Intensive Care
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Premature Birth; Bronchopulmonary Dysplasia; Organic Chemicals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Diterpenes; Vitamin A
• Other Study ID Numbers: VITA-BPD-2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional and ethical restrictions, including patient confidentiality and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No