CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Nutrof Total +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01404845
NCT01404845N/ACompleted

Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).

Affordance·interventional·Posted Jul 28, 2011·Updated Jun 24, 2015

In Brief

A clinical study evaluating Nutrof Total and food supplement without Lutein and Zeaxanthin for Exudative Age-related Macular Degeneration. Completed, enrolled 200 participants across 2 sites.

Detailed Summary

•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits. •Primary outcome: Comparative analysis of the density and evolution of the density of macular pigment: * In patients without any retinal pathology who underwent cataract surgery 1 month previously * In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye * Secondary outcomes: Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator): * Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements) * Time taken to return to the baseline macular pigment density after cessation of supplementation * Study design : Pilot study -Prospective, randomised, double-masked, comparative, multicenter.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsDrescode

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.9 years ago

Interventions

Nutrof Totaldietary

Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).

food supplement without Lutein and Zeaxanthindietary

food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.