LIMPIA: Lutein Influence on Macula of Persons Issued From Amd Parents

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01269697

Collaborator

Laboratoires Thea (Industry)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persons Issued From Amd Parents	Dietary Supplement: Nutrof Total Dietary Supplement: Placebo Nutrof total	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Lutein Influence on Macula of Persons Issued From Amd Parents

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nutrof patient receive the treatment of Nutrof Total	Dietary Supplement: Nutrof Total 2 capsules 2 times per day during 6 month
Placebo Comparator: Placebo of Nutrof Patient receive the treatment of the placebo of Nutrof Total	Dietary Supplement: Placebo Nutrof total 2 capsules 2 times per day during 6 month

Arm

Intervention/Treatment

Active Comparator: Nutrof

patient receive the treatment of Nutrof Total

Dietary Supplement: Nutrof Total

2 capsules 2 times per day during 6 month

Placebo Comparator: Placebo of Nutrof

Patient receive the treatment of the placebo of Nutrof Total

Dietary Supplement: Placebo Nutrof total

2 capsules 2 times per day during 6 month

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin	Bordeaux		France	33076
2	Service Ophtalmologie - Hôpital général CHU de Dijon	Dijon		France	21000

Sponsors and Collaborators

University Hospital, Bordeaux
Laboratoires Thea

Investigators

Principal Investigator: Jean-François KOROBELNIK, Professor, University Hospital Bordeaux, France
Study Chair: Geneviève CHENE, Professor, University Hospital Bordeaux, France