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

NCT02102711 | Completed DMC

• 1 other identifier: VITA-1-OS
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bronchopulmonary Dysplasia; Retinopathy of Prematurity

Keywords

VITAMIN A; BLOOD CONCENTRATION; retinopathy of prematurity

Outcome Measures

Primary Outcomes (1)

• Vitamin A blood concentration (µM/L)

  Vitamin A functional concentration

  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

  1 year

Study Arms (2)

vitaminA drops

EXPERIMENTAL

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

Dietary Supplement: Vitamin A oral drops

control

NO INTERVENTION

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

Interventions

Vitamin A oral drops DIETARY_SUPPLEMENT

Also known as: VISPO, BIOTRADING Pharma

vitaminA drops

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Francesca Garofoli: lead

Study Sites (2)

IRCCS Policlinico S. Matteo

Pavia, PV, 27100, Italy

Location

IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 32493448 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Diseases; Eye Diseases

Study Officials

• Mauro Stronati, MD

  IRCCS Policlinico S. Matteo, Pavia, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)