MedTrace Logo

Evaluation of Antioxidant Activity of Oral Lutein in Preterm and Term Newborn

NCT02068807 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-02-25

No results posted yet for this study

Summary

The balance of the redox state is important for normal embryonic and fetal development . During the perinatal period, a variety of conditions are responsible for an excessive production of free radicals. The following oxidative stress is exacerbated by a lack of antioxidant substances that have not yet matured. At the moment there are no therapeutic strategies with single or combined antioxidants that have been shown to be clinically effective.

Breastfeeding is important for the contribution of the antioxidant defenses of the newborn and the nutritional status of the mother plays a key role because it influences the nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body , but taken with food or supplements. The molecule carries out different activities : antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of inhibition of peroxidation of membrane lipids is peculiarly important for the photoreceptors and neurons whose membranes are rich with polyunsaturated fatty acids. Current evidence on its role as an antioxidant indicate that supplementation with lutein may play a significant role in the prevention of free radical disease in the newborn

Conditions

  • Infant, Newborn, Diseases
  • Other Lipid Storage Disorders

Interventions

DIETARY_SUPPLEMENT

Lutein drops

After randomisation, the infant received orally a total dose of 0.28 mg of lutein in two doses: within 6 hours after birth and at 36 hours of life

DIETARY_SUPPLEMENT

Glucose drops

After randomization, newborns received 0.5 mL of 5% glucose solution in two doses: within 6 hours (hrs) after birth and at 36 hrs of life.

Sponsors & Collaborators

  • Careggi Hospital

    collaborator OTHER

  • University of Siena

    lead OTHER

Principal Investigators

  • Giuseppe Buonocore, Prof · University of Siena

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-10-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068807 on ClinicalTrials.gov