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

NCT02068807 | Completed Phase 1

• 1 other identifier: NEO-LUT-2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Antioxidant status in the newborns

  First days of life

Study Arms (2)

Lutein drops

ACTIVE COMPARATOR

oral administration of 0.28 mg of lutein in two doses: within 6 hours (hrs) after birth and at 36 hrs of life

Dietary Supplement: Lutein drops

Glucose drops

PLACEBO COMPARATOR

oral administration of 0.28 mg of vehicle (0.5 mL of 5% glucose solution) in two doses: within 6 hours (hrs) after birth and at 36 hrs of life

Dietary Supplement: Glucose drops

Interventions

Lutein drops DIETARY_SUPPLEMENT

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

Lutein drops

Glucose drops DIETARY_SUPPLEMENT

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.

Glucose drops

Eligibility Criteria

• Age: 1 Minute - 5 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• healthy singleton term newborns discharged on third day of life whose mothers had low-obstetric risk and with normal adaptation to extrauterine life

Sponsors & Collaborators

• University of Siena: lead
• Careggi Hospital: collaborator

Study Sites (1)

AOUS

Siena, Italy, 53100, Italy

Location

Related Publications (1)

• Perrone S, Tei M, Longini M, Santacroce A, Turrisi G, Proietti F, Felici C, Picardi A, Bazzini F, Vasarri P, Buonocore G. Lipid and protein oxidation in newborn infants after lutein administration. Oxid Med Cell Longev. 2014;2014:781454. doi: 10.1155/2014/781454. Epub 2014 Apr 30.

  PMID: 24876916 DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Giuseppe Buonocore, Prof

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 21, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IT (1)