Lutein Influence on Macula of Persons Issued From Amd Parents
NCT ID: NCT01269697
Last Updated: 2013-05-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2013-01-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Persons Issued From Amd Parents
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Nutrof
patient receive the treatment of Nutrof Total
Group Type
ACTIVE_COMPARATOR
Nutrof Total
Intervention Type
DIETARY_SUPPLEMENT
2 capsules 2 times per day during 6 month
Placebo of Nutrof
Patient receive the treatment of the placebo of Nutrof Total
Group Type
PLACEBO_COMPARATOR
Placebo Nutrof total
Intervention Type
DIETARY_SUPPLEMENT
2 capsules 2 times per day during 6 month
Interventions
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Nutrof Total
2 capsules 2 times per day during 6 month
Intervention Type
DIETARY_SUPPLEMENT
Placebo Nutrof total
2 capsules 2 times per day during 6 month
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Laboratoires Thea
INDUSTRY
Sponsor Role
collaborator
University Hospital, Bordeaux
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jean-François KOROBELNIK, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Geneviève CHENE, Professor
Role: STUDY_CHAIR
University Hospital Bordeaux, France
Locations
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Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin
Bordeaux, , France
Site Status
Service Ophtalmologie - Hôpital général CHU de Dijon
Dijon, , France
Site Status
Countries
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France
References
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Reference Type
DERIVED
Other Identifiers
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CHUBX 2009/31
Identifier Type: -
Identifier Source: org_study_id
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