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临床试验/NCT03340103
NCT03340103撤回不适用

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

Sooft Italia4 个研究点 分布在 1 个国家开始时间: 2018年10月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
4
主要终点
Change of the lutein's antioxidant power, after early oral administration in premature newborns

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Pilot study, non-commercial, with food supplement, treated vs. control with a ratio 1: 1 double-blind. The identical vials, corresponding to placebo and active product, have an alphanumeric code without meaning for the operator, but that identifies the treaties from controls, in an anonymous document kept by the Statistical. The document will be placed in a sealed and anonymous envelope and it will be kept open by the statistician at the time of data analysis.

入排标准

年龄范围
24 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Experimental group A

Experimental

Group 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.

干预措施: LUTEIN ofta 0,5 gocce (Dietary Supplement)

Control group B

Placebo Comparator

Group 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.

干预措施: Placebo (Drug)

结局指标

主要结局

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

时间窗: 0 day - 15 days - 30 days

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

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

时间窗: 0 day - 15 days - 30 days

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

次要结局

未报告次要终点

研究者

发起方
Sooft Italia
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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