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Completed

NCT Number: NCT01269697

Lutein Influence on Macula of Persons Issued From Amd Parents

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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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrof Total

Dietary Supplement

2 capsules 2 times per day during 6 month

Placebo Nutrof total

Dietary Supplement

2 capsules 2 times per day during 6 month

Primary outcomes

  1. 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

    Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation

Secondary outcomes

  1. Measure of the modification of the visual acuteness with correction

    Time frame: 12 months

  2. Measure of the cognitive capacities

    Time frame: 12 months

  3. Measure rates plasmatiques of fatty acids

    Time frame: 12 months

  4. Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Laboratoires Thea

Registry information

Acronym: LIMPIA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2011
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.