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Persons Issued From Amd ParentsPhase 3LIMPIANCT01269697

Lutein Influence on Macula of Persons Issued From Amd Parents

A Phase 3 study testing Nutrof Total in people with Persons Issued From Amd Parents, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Persons Issued From Amd Parents
What is being tested?
Nutrof Total
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesFrance
Study dates
Jan 2011to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Subjects not compliants
  • Subjects not flatware by the system of social security
  • Subjects under guardianship judicial

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

    Bordeaux, 33076

  • Service Ophtalmologie - Hôpital général CHU de Dijon

    Dijon, 21000

Other trials in France

About this study

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.

Read the 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

Being tested
Nutrof Total, Placebo Nutrof total
Keywords
AMD, food supplementation, macular pigments, luthéine, zéaxanthine, visual acuity, prevention, genetique risk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrof TotalDietary supplement

    2 capsules 2 times per day during 6 month

  • Placebo Nutrof totalDietary supplement

    2 capsules 2 times per day during 6 month

Study groups in NCT01269697
Study groupRoleWhat they receive
NutrofActive comparatorpatient receive the treatment of Nutrof Total
Receives: Dietary Supplement: Nutrof Total
Placebo of NutrofPlacebo comparatorPatient receive the treatment of the placebo of Nutrof Total
Receives: Dietary Supplement: Placebo Nutrof total

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation

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

    Measured: 6 months after stop of the supplementation

Secondary outcomes (4)

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

    Measured: 12 months

  2. Measure of the cognitive capacities

    Measured: 12 months

  3. Measure rates plasmatiques of fatty acids

    Measured: 12 months

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

    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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01269697
Sponsor's protocol ID
CHUBX 2009/31
Acronym
LIMPIA
Status last verified
May 2013
First submitted
3 Jan 2011
Last updated
20 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

    PubMed 15640920

  • Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. No abstract available.

    PubMed 18550876

  • Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.

    PubMed 11594942

  • Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. doi: 10.1001/archopht.124.7.1038.

    PubMed 16832030

  • Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. doi: 10.1001/archopht.1993.01090010108035.

    PubMed 7678730

  • Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5. doi: 10.1167/iovs.02-0929.

    PubMed 12766044

  • Delcourt C, Carriere I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35. doi: 10.1167/iovs.05-1235.

    PubMed 16723441

  • Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. doi: 10.1016/j.ophtha.2007.03.083. Epub 2007 Jul 30.

    PubMed 17664009

  • Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43. doi: 10.1093/ajcn/87.6.1837.

    PubMed 18541575

  • VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study. Am J Epidemiol. 1998 Jul 15;148(2):204-14. doi: 10.1093/oxfordjournals.aje.a009625.

    PubMed 9676703

  • Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92. doi: 10.1001/archopht.122.6.883.

    PubMed 15197064

  • van Leeuwen R, Boekhoorn S, Vingerling JR, Witteman JC, Klaver CC, Hofman A, de Jong PT. Dietary intake of antioxidants and risk of age-related macular degeneration. JAMA. 2005 Dec 28;294(24):3101-7. doi: 10.1001/jama.294.24.3101.

    PubMed 16380590

  • Beatty S, Murray IJ, Henson DB, Carden D, Koh H, Boulton ME. Macular pigment and risk for age-related macular degeneration in subjects from a Northern European population. Invest Ophthalmol Vis Sci. 2001 Feb;42(2):439-46.

    PubMed 11157880

  • Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EE. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):235-40.

    PubMed 11133874

  • Bernstein PS, Zhao DY, Wintch SW, Ermakov IV, McClane RW, Gellermann W. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002 Oct;109(10):1780-7. doi: 10.1016/s0161-6420(02)01173-9.

    PubMed 12359594

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nutrof Total in people with Persons Issued From Amd Parents, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01269697, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.

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