NCT03340103

Early Administration of the Lutein/Zeaxanthin in Premature Newborns

Withdrawn NA Last updated 2 November 2020

What this trial tests

NA trial testing LUTEIN ofta 0,5 gocce in Antioxidant Role of the Lutein in Preterm Newborn. Withdrawn.

Timeline

11 October 2018

Primary endpoint
11 October 2019

11 October 2019

Quick facts

Lead sponsor	Sooft Italia
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Start date	11 October 2018
Primary completion	11 October 2019
Estimated completion	11 October 2019
Sites	4 locations across Italy

Drugs / interventions tested

• LUTEIN ofta 0,5 gocce
• Placebo

Conditions studied

• Antioxidant Role of the Lutein in Preterm Newborn — all drugs for Antioxidant Role of the Lutein in Preterm Newborn →

Sponsor

Sooft Italia

Who can join

Adults 24 Weeks to 32 Weeks, any sex, with Antioxidant Role of the Lutein in Preterm Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system (intraventricular hemorrhage IVH), in the lungs (bronchial pulmonary dysplasia BPD), in the gut (NEC) and infections. Oxidative stress has been implicated in various capacities, in the etiology of these conditions. Lutein and Zeaxanthin are powerful anti-oxidants and commonly assimilated with different foods. Lutein and Zeaxanthin are present at level of umbilical cord, in the breast milk (particularly in colostrum) and pass the placental barrier. Concerning supplementations, the lutein presents, for its specific characteristics, a high bioavailability after oral administration. In the last few years, there have been more and more studies which have shown that lutein could constitute a valid and important preventive and protective factor against certain diseases related to oxidative stress. The preparations of lutein and zeaxanthin have never pointed out in the human being (included in the term newborn) adverse or toxic effects. This spontaneous / non-commercial pilot study involves the administration of a dietary supplement containing lutein / zeaxanthin, because the healthcare structures need to identify a natural antioxidant product that can reduce the incidence of serious diseases related to oxidative stress in the perinatal period. This study aims to evaluate if the administration of lutein in watery solution will reduce the rate of free radicals in preterm infants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enteral Bioactive Factor Supplementation in Preterm Infants: A Systematic Review.
   Mank E, Naninck EFG, Limpens J, van Toledo L, et al · · 2020 · cited 7× · PMID 32987621 · DOI 10.3390/nu12102916