Lutein Influence on Macula of Persons Issued From Amd Parents

Phase 3

Completed

• Conditions: Persons Issued From Amd Parents
• Interventions: Dietary Supplement: Nutrof Total; Dietary Supplement: Placebo Nutrof total

• Registration Number: NCT01269697
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.

Detailed Description

The objective of this study is to estimate the efficiency of a nutritonal supplementation with lutein and zeaxanthin to increase their plasma concentration and the density of macular pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of supplementation versus placebo

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Men or women 40 to 70 years old
• Presenting histories of wet AMD with their father or their mother or 2
• Visual acuity of 20/25 or better (ETDRS)
• The presence of a AMD in one eye is possible
• Enlightened consent writes, dated and signed by the participant and the investigator above all examination required by the research.
• Subject agreeing to be registered in the national file
• Affiliated or profitable subject of a national insurance scheme

Exclusion Criteria

• Presence of signs of AMD in both eyes (if AMD in one eye, inclusion for the other eye is possible)
• Histories of the other evolutionary eye pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (severe glaucoma, strong nearsightedness (superior or more equal in - 6 dioptres), the other severe rétinopathie)
• Subject with history of cataract surgery
• Opaqueness preventing the evaluation of the photos of the retina (cataract, corneal dystrophy)
• Supplementation with food complements in the year which precedes (cf. appendix 2 of the protocol)
• Participation in another clinical trial during 30 days which precede
• Subjects not compliants
• Subjects not flatware by the system of social security
• Subjects under guardianship judicial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrof	Nutrof Total	patient receive the treatment of Nutrof Total
Placebo of Nutrof	Placebo Nutrof total	Patient receive the treatment of the placebo of Nutrof Total

Primary Outcome Measures

Name	Time	Method
The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation	6 months after stop of the supplementation	Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation

Secondary Outcome Measures

Name	Time	Method
Measure of the modification of the visual acuteness with correction	12 months
Measure of the cognitive capacities	12 months
Measure rates plasmatiques of fatty acids	12 months
Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation	1 year	Measure of the density of the macular pigment before supplementation, in 3 and 6 months during the supplementation and in 3 and 6 months after stop of the supplementation

Trial Locations

Locations (2)

Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin; 🇫🇷 Bordeaux, France

Service Ophtalmologie - Hôpital général CHU de Dijon; 🇫🇷 Dijon, France