- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102711
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g Efficacy and Tolerability in the Prevention of Bronchopulmonary Dysplasia (BDP) and Retinopathy of the Prematurity (ROP)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pavia, Italy, 27100
- IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
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PV
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Pavia, PV, Italy, 27100
- IRCCS Policlinico S. Matteo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- parents denied informed consent
- congenital malformations
- infants not able to receive breast or formula milk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: vitaminA drops
3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.
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Other Names:
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No Intervention: control
Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin A blood concentration (µM/L)
Time Frame: participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks
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Vitamin A functional concentration
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participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of bronchopulmonary dysplasia and of retinopathy of prematurity
Time Frame: 1 year
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number of events
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Mauro Stronati, MD, IRCCS Policlinico S. Matteo, Pavia, Italy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Eye Diseases
- Infant, Newborn, Diseases
- Body Weight
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Lung Injury
- Infant, Premature, Diseases
- Ventilator-Induced Lung Injury
- Retinal Diseases
- Premature Birth
- Birth Weight
- Retinopathy of Prematurity
- Bronchopulmonary Dysplasia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin A
Other Study ID Numbers
- VITA-1-OS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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