CClinicalTrials.gg
CompletedNCT02102711Updated Jul 25, 2024

Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g

An interventional study of Vitamin A oral drops in Bronchopulmonary Dysplasia and Retinopathy of Prematurity, sponsored by Francesca Garofoli. Completed at 2 sites in Italy. Open to participants aged 1 Day to 7 Days. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Francesca Garofoli · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
1 Day to 7 Days
Sex
All
01

Study summary

Vitamin A is essential for optimal growth, and development. In the newborn, especially if preterm, it is necessary for the cellular differentiation, for the health of the anterior eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis. Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very low (\<1500g birth weight) and extremely low (\<1000g birth weight) preterm infants are born with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless, optimal vitamin A supplementation for these infants is not clearly defined, despite evidence of benefit of an early supplementation.

Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease marked by respiratory compromise associated with high mortality and severe long-term morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that may be related to less rhodopsin quantity which seem dependent on vitamin A concentration. Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral administration as drops is available resulting particularly convenient avoiding the pain associated with repetitive intramuscular injections, or the discomfort of parenteral administration. Studies of vitamin A in the infant population suggest that plasma retinol concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have lower concentration and concentration \< 0.35 µM/L are very dangerous. Vitamin A deficiency at this level may constitute a problem for preterm newborn, resulting for example, in histological alterations in the respiratory epithelium leading to chronic lung disease, retinopathy of prematurity, patency of the ductus arteriosis, and immune competence deficiency.

The aim of the present study is to verify efficacy and tolerability of a new oral administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants \< 1500g weight at birth, verifying the competence of the supplementation reaching ideal blood concentration (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the controlarm.

02

Conditions studied

  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity

Keywords

  • VITAMIN A
  • BLOOD CONCENTRATION
  • retinopathy of prematurity
03

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 62 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

Francesca Garofoli is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • parents signed informed consent
  • very low birth weight infants undergoing ventilation for at least 24 hours
  • Infants able to receive adequate breast or formula milk

Exclusion criteria

Exclusion Criteria:

  • parents denied informed consent
  • congenital malformations
  • infants not able to receive breast or formula milk
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    vitaminA drops

    3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.

    Dietary Supplement: Vitamin A oral drops

  • No intervention
    control

    Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)

Interventions

  • Dietary supplementVitamin A oral drops

    Also known as: VISPO, BIOTRADING Pharma

06

What researchers measure

Primary outcomes

  1. Vitamin A blood concentration (µM/L)

    Vitamin A functional concentration

    Time frame: participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks

Secondary outcomes

  1. number of bronchopulmonary dysplasia and of retinopathy of prematurity

    number of events

    Time frame: 1 year

07

Study locations

2 sites
  • IRCCS Policlinico S. Matteo
    Pavia, PV 27100, Italy
  • IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
    Pavia, 27100, Italy
08

References and documents

Publications

  • Garofoli F, Barilla D, Angelini M, Mazzucchelli I, De Silvestri A, Guagliano R, Decembrino L, Tzialla C. Oral vitamin A supplementation for ROP prevention in VLBW preterm infants. Ital J Pediatr. 2020 Jun 3;46(1):77. doi: 10.1186/s13052-020-00837-0. PubMed 32493448 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02102711
Lead sponsor
Francesca Garofoli
Responsible party
Francesca Garofoli (doctor, Fondazione IRCCS Policlinico San Matteo di Pavia) — Sponsor-investigator
First posted
Apr 3, 2014
Start date
Apr 2014
Primary completion
Apr 2015
Completion
Apr 2016
Last update
Jul 25, 2024

Study contacts

Mauro Stronati, MD
study director · IRCCS Policlinico S. Matteo, Pavia, Italy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion