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Antioxidant Role of the Lutein in Preterm NewbornNCT03340103

Early Administration of the Lutein/Zeaxanthin in Premature Newborns

A study testing LUTEIN ofta 0,5 gocce in people with Antioxidant Role of the Lutein in Preterm Newborn, run by Sooft Italia at 4 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 24 to 32 weeks
What is being tested?
LUTEIN ofta 0,5 gocce
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
4 sitesItaly
Study dates
11 Oct 2018to 11 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Newborns with a body weight at birth ≤ 1.500 grams and/or gestational age ≤ 32 weeks
  • Male and female newborns
  • Newborns whose parents want to sign the informed consent
  • Informed consent

Who cannot join

  • Informed consent is not signed
  • Infants with a body weight at birth ≥ 1.500 gramms and/or gestational age > 32 weeks
  • Infants hospitalized after 36 hours of life
  • Infants with Ophthalmologic diseases
  • Infants with severe malformations

Trial locations and contacts

4 sites in 1 country.

Italy4 sites
  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Azienda Ospedaliera Universitaria Padova

    Padova, Italia, 35128

  • University Hospital Perugia

    Perugia, 06121-06135

  • Azienda Ospedaliera Le Scotte Siena

    Siena, Italia, 53100

Other trials in Italy

About this study

Official title: Evaluation of the Antioxidant Activity of Lutein/Zeaxanthin Early Administered to Premature Newborns

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.

Read the detailed description

Lutein is the most important carotenoid present selectively in certain tissues of the human body, mainly at the level of the retina, macula (hence the name) and lens. In tissues and serum, lutein is found together with a carotenoid dihydroxide, its isomer, zeaxanthin. Lutein and zeaxanthin are present at the level of the umbilical cord and pass through the placental barrier and are also present in the plasmatic ones, in breast milk and especially in the colostrum. Concerning the way of administrating, the lutein presents, through its specific characteristics, an elevated bioavailability after oral administration. The hematic levels of lutein, after providing nutriments rich in carotenoids, are increased with 67% from the 14% observed at beta-carotene. Through interdisciplinary and coordinated studies, performed both in vitro and in vivo, there were identified different action mechanisms; particularly, investigators have demonstrated a defense mechanism of the tissue function by lutein, which is produced through the neutralization (quench) phenomenon of the singlet oxygen and reactive oxygen species (ROS). This action provides molecules with different activities: an antioxidant function, anti-inflammatory properties, properties which promote anti-tumoral effects, induction of detoxification enzymes and positive effect on proteins promoting the communication between joints (up-regulation). Recently, there have appeared experimental and chemical data proving that the oxidative stress and harmful actions determined by ROS can play an important role in the pathogenesis of many neurological diseases as Alzheimer, Parkinson in adult and ROP and NEC in newborns.

This is due to the fact that the nervous system is characterized by membranes rich in polyunsaturated fats, the first cellular compounds affected by ROS attack through the lipid peroxidation. A similar mechanism can appear to certain ocular tissues (macula, lens, retina) which, containing high amounts of polyunsaturated fat acids, are more vulnerable than other structures with oxidative degradations induced by ROS.

Due to the fact that carotenoids are amongst the most powerful antioxidants existing in nature, there are being developed new researches concerning the functional role of these substances in preventing neurodegenerative diseases in newborns.

Because these polyunsaturated fat acids are very sensitive to oxidation, the modification of their plasmatic levels influences the state of the antioxidant systems on the mother and subsequently to the foetus. Many studies have proved that the increase of the susceptibility to the peroxidation of polyunsaturated fat acids on pregnant women is accompanied by an equivalent increase of the tocopherol plasmatic concentration which, immediately after birth, decrease sharply.

The plasmatic concentrations of the newborns' antioxidants were lower than those of the mothers. In the umbilical cord, the levels of tocopherols and carotenoids are significantly lower than the ones registered in the maternal plasma and the concentration of polyunsaturated fat acids on the newborn is significantly higher and a lot more increased than on the mother.

Furthermore, specific studies showed a growing interest towards the oxidative stress and oxygen reactive species which supposedly accumulate after birth. Many practices usually used in the delivery room (for example the drugs given to pregnant woman to ease her pain, the newborns' extraction methods, the techniques to minimize body temperature decrease, blocking the umbilical cord and especially the use of oxygen to 100 % or a ventilated room for newborns presenting asphyxia signs) do not always prove to be efficient and can also compromise the health of the newborn because of a significant increase of free radicals.

Some specific studies have compared the levels of free radicals, highlighted with markers, in the plasma of the umbilical cord of newborns with asphyxia treated 100% with oxygen or 21% with oxygen, comparative to a control group of children without asphyxia. The levels of free radicals were significantly increased immediately after birth in all three groups and grew in the two groups of newborns with asphyxia. In the group treated 21% with oxygen, these values decreased and have reached the same level of the newborns without asphyxia at 28 days after birth, whereas at the group treated 100% with oxygen the levels of free radicals remained very high.

Thus, a short exposure of the newborn to 100% oxygen is the cause of an extended oxidative stress state and a consistent increase of free radicals, which seem to be involved in different diseases and pathologies during the first months of life, especially in the preterm infant increasing significantly the incidence of ROP, IVH, BPD, NEC and infections.

These results show that the newborn need to increase the level of antioxidant protection to establish the redox balance and to prevent the problems occurred from an extended exposure to high levels of free radicals and oxygen reactive species.

The premature birth is the most frequent cause of mortality, morbidity and disability. Premature babies have an extremely high risk to develop ocular or neurological lesions. The main complication at visual level that may appear is called retinopathy of prematurity, so called ROP. Oxidative stress is involved in the etiology of this disease. In fact, premature babies, because of respiratory issues, are often exposed to potentially damaging oxygen concentrations or to phototherapy with high blue light intensity. These therapeutic practices are sources of free radicals.

The studies performed on the babies showed that the levels of carotenoids in the first four / six months of life are much reduced. This is due to the fact that the baby's diet is based exclusively on milk, without any solid elements (as vegetables or green leaves), sole sources of this nutrient. Nevertheless, breastfed babies, in average, present high plasmatic lutein levels than babies fed with prepared milk. Different milk formulas for newborns found at present time on the market are not enriched with this type of carotenoids, thus their content of lutein and zeaxanthin is very low, except certain formulas which are not traded in Italy and prepared using egg mixes. Breast milk, is thus the only source of lutein for the newborn before weaning, and breast feeding proves to be of considerable importance as primary source of these micronutrients for the newborn, proper development and visual function protection. Taking into consideration the correlation between the lutein in the blood and breast milk and the reduction of its levels, similar to all carotenoids, in milk, after 6 days from birth, there is already an important contribution of nutriments high in lutein during breast feeding. Such diet enriched in lutein is particularly important especially for the mothers of premature babies or babies having a small body weight when born. In fact, premature babies and underweight babies need more nutritive essential substances for a fast grow. These babies have not benefit from the contribution of highly nutritive and energetic substances transferred from their mothers during the last weeks of pregnancy. Also, the gastrointestinal and renal functions which are not completely developed reduce the absorption and withhold of important micronutrients, amongst which important antioxidants that protect the newborn from the exposure to high level of free radicals produced excessively at birth and several times as a result of the resuscitation techniques used. Breast feeding is important for the antioxidant contribution to the protection of the newborn and the nutritional state of the mother has subsequently an essential part because it influences the nutrition of the newborn, especially concerning certain solvable nutritive elements, such as lutein and zeaxanthin.

In the literature are already present researches and results with the use of lutein / zeaxanthin in the newborn.

The recent Gong's work has evaluated the role of lutein / zeaxanthin comparing the data obtained from various studies, including those of Romagnoli, Dani and Manzoni. Furthermore, thanks to RCT analysis of Rubin on the subject, investigators concluded that lutein / zeaxanthin is well tolerated and well absorbed from preterm infants also after oral administration.

The extremely interesting result that has emerged although not statistically significant (probably due to the small sample) is that supplementation with lutein / zeaxanthin reduced the incidence and severity of ROP.

This protocol is born from the idea that given the interesting results of earlier work is considered important to deepen a dosage of at least 1 ml / kg equal to 0,5 mg of lutein and 0.05 mg of zeaxanthin.

The evaluation of the key markers for oxidative stress is necessary along with the study of the biological antioxidant potential (BPT) and total hydroperoxide (TH) during and after treatment.

Already in a previous work, S. Perrone and M. Longini have demonstrated a reduction of the free radicals in term infants, during and after administration of lutein / zeaxanthin by determination of the BTP and TH.

Preparations based on lutein and zeaxanthin have never revealed on humans negative or harmful effects after administration, or to the gastrointestinal or systemic level. In recent studies there were not reported adverse phenomena after administrating 20 mg/day of lutein or zeaxanthin for a period of 6 months, or interactions with other liposoluble nutritive elements.

Being tested
LUTEIN ofta 0,5 gocce, Placebo
Keywords
Lutein/Zeaxanthin, Antioxidant, Oxidative stress, Carotenoid, Preterm newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUTEIN ofta 0,5 gocceDietary supplement

    LUTEIN ofta 0,5 gocce, containing a solution of 5% Lutein and 2,5% Zeaxanthin with excipients (Corn starch, glucose, potassium sorbate, xanthan gum, citric acid)

  • PlaceboDrug

    Placebo solution with unique excipients (Demineralised water, potassium sorbate, xanthan gum, citric acid)

Study groups in NCT03340103
Study groupRoleWhat they receive
Experimental group AExperimentalGroup A (18 newborns) will be treated with LUTEIN ofta 0,5 drops, (1 ml per Kg equal to 0,5 mg of lutein and 0,05 of zeaxantin) additionaly to the standard hospital treatment foreseen. The first dose will be given within 36 hours of life, the least to 30th day of life.
Receives: Dietary Supplement: LUTEIN ofta 0,5 gocce
Control group BPlacebo comparatorGroup B (18 newborns) treated with Placebo solution additionaly to the standard hospital treatment foreseen. The first dose will be given within 36 hours of life, the least to 30th day of life.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the lutein's antioxidant power, after early oral administration in premature newborns

    Biological antioxidant potential (micromol/L) will be analyzed as marker of the antioxidant power. This marker will be tested at birth (0 day) by blood sampling from umbilical vein, while at 15 days and 30 days by peripheral blood

    Measured: 0 day - 15 days - 30 days

  2. Change of the premature newborns' oxidative stress, after early oral administration of the lutein

    Total hydroperoxide (Ucarr) will be analyzed as marker of the oxidative stress. This marker will be tested at birth (0 day) by blood sampling from umbilical vein, while at 15 days and 30 days by peripheral blood

    Measured: 0 day - 15 days - 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2017
  2. Study start11 Oct 2018
  3. Primary completion11 Oct 2019 (estimated)
  4. Study completion11 Oct 2019 (estimated)

Why it stopped: Recruitment was not possible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Since birth, premature newborns, that are comply with the inclusion parameters, will be introduced and separated in two random groups (A and B). All newborns, during the observation period, will be submitted to the blood collection (1 ml) from the umbilical cord and peripheral site (at the same time with the routine collections) on which there will be performed blood gas analysis and oxidative stress markers (TH and BAP)
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03340103
Sponsor's protocol ID
3172 10/10/2018
Status last verified
Oct 2020
First submitted
17 Oct 2017
Last updated
2 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lorenzoni F, Giampietri M, Ferri G, Lunardi S, Madrigali V, Battini L, Boldrini A, Ghirri P. Lutein administration to pregnant women with gestational diabetes mellitus is associated to a decrease of oxidative stress in newborns. Gynecol Endocrinol. 2013 Oct;29(10):901-3. doi: 10.3109/09513590.2013.808329. Epub 2013 Jun 28.

    PubMed 23808391
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343
  • Gerardi G, Usberti M, Martini G, Albertini A, Sugherini L, Pompella A, Di LD. Plasma total antioxidant capacity in hemodialyzed patients and its relationships to other biomarkers of oxidative stress and lipid peroxidation. Clin Chem Lab Med. 2002 Feb;40(2):104-10. doi: 10.1515/CCLM.2002.019.

    PubMed 11939481
  • Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.

    PubMed 8660627
  • Cohen, J. (1969). Statistical power analysis for the behavioural sciences. New York: Academic Press

  • Shao A, Hathcock JN. Risk assessment for the carotenoids lutein and lycopene. Regul Toxicol Pharmacol. 2006 Aug;45(3):289-98. doi: 10.1016/j.yrtph.2006.05.007. Epub 2006 Jun 30.

    PubMed 16814439
  • Khachik F, London E, de Moura FF, Johnson M, Steidl S, Detolla L, Shipley S, Sanchez R, Chen XQ, Flaws J, Lutty G, McLeod S, Fowler B. Chronic ingestion of (3R,3'R,6'R)-lutein and (3R,3'R)-zeaxanthin in the female rhesus macaque. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5476-86. doi: 10.1167/iovs.06-0194.

    PubMed 17122139
  • Khachik F, de Moura FF, Chew EY, Douglass LW, Ferris FL 3rd, Kim J, Thompson DJ. The effect of lutein and zeaxanthin supplementation on metabolites of these carotenoids in the serum of persons aged 60 or older. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5234-42. doi: 10.1167/iovs.06-0504.

    PubMed 17122108
  • Trevithick-Sutton CC, Foote CS, Collins M, Trevithick JR. The retinal carotenoids zeaxanthin and lutein scavenge superoxide and hydroxyl radicals: a chemiluminescence and ESR study. Mol Vis. 2006 Sep 30;12:1127-35.

    PubMed 17093397
  • Thurmann PA, Schalch W, Aebischer JC, Tenter U, Cohn W. Plasma kinetics of lutein, zeaxanthin, and 3-dehydro-lutein after multiple oral doses of a lutein supplement. Am J Clin Nutr. 2005 Jul;82(1):88-97. doi: 10.1093/ajcn.82.1.88.

    PubMed 16002805
  • Rajendran V, Pu YS, Chen BH. An improved HPLC method for determination of carotenoids in human serum. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Sep 25;824(1-2):99-106. doi: 10.1016/j.jchromb.2005.07.004.

    PubMed 16046287
  • During A, Dawson HD, Harrison EH. Carotenoid transport is decreased and expression of the lipid transporters SR-BI, NPC1L1, and ABCA1 is downregulated in Caco-2 cells treated with ezetimibe. J Nutr. 2005 Oct;135(10):2305-12. doi: 10.1093/jn/135.10.2305.

    PubMed 16177187
  • Reboul E, Abou L, Mikail C, Ghiringhelli O, Andre M, Portugal H, Jourdheuil-Rahmani D, Amiot MJ, Lairon D, Borel P. Lutein transport by Caco-2 TC-7 cells occurs partly by a facilitated process involving the scavenger receptor class B type I (SR-BI). Biochem J. 2005 Apr 15;387(Pt 2):455-61. doi: 10.1042/BJ20040554.

    PubMed 15554873
  • Lutein and zeaxanthin. Monograph. Altern Med Rev. 2005 Jun;10(2):128-35. No abstract available.

    PubMed 15989382
  • Krinsky NI, Landrum JT, Bone RA. Biologic mechanisms of the protective role of lutein and zeaxanthin in the eye. Annu Rev Nutr. 2003;23:171-201. doi: 10.1146/annurev.nutr.23.011702.073307. Epub 2003 Feb 27.

    PubMed 12626691

Questions about this trial

What is this clinical trial studying?

A study testing LUTEIN ofta 0,5 gocce in people with Antioxidant Role of the Lutein in Preterm Newborn, run by Sooft Italia at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the lutein's antioxidant power, after early oral administration in premature newborns (time frame: 0 day - 15 days - 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03340103, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.

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