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

U

University Hospital of Bordeaux

Status and phase

Completed
Phase 3

Conditions

Persons Issued From Amd Parents

Treatments

Dietary Supplement: Placebo Nutrof total
Dietary Supplement: Nutrof Total

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01269697
CHUBX 2009/31

Details and patient eligibility

About

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.

Full 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

Enrollment

120 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Nutrof
Active Comparator group
Description:
patient receive the treatment of Nutrof Total
Treatment:
Dietary Supplement: Nutrof Total
Placebo of Nutrof
Placebo Comparator group
Description:
Patient receive the treatment of the placebo of Nutrof Total
Treatment:
Dietary Supplement: Placebo Nutrof total

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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