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Lutein Influence on Macula of Persons Issued From Amd Parents (LIMPIA)

This study has been completed.
Sponsor:
Collaborator:
Laboratoires Thea
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01269697
First received: January 3, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Persons Issued From Amd Parents
 Dietary Supplement: Nutrof Total
Dietary Supplement: Placebo Nutrof total
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Lutein Influence on Macula of Persons Issued From Amd Parents

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

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 [ Time Frame: 6 months after stop of the supplementation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure of the cognitive capacities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure rates plasmatiques of fatty acids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Enrollment: 120
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269697

Locations
France
Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin
Bordeaux, France, 33076
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
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01269697     History of Changes
Other Study ID Numbers: CHUBX 2009/31
Study First Received: January 3, 2011
Last Updated: May 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
AMD
food supplementation
macular pigments
luthéine
 zéaxanthine
visual acuity
prevention
genetique risk

ClinicalTrials.gov processed this record on May 23, 2013