drugset / Trial / NCT01048476

Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration

NCT01048476

Phase 1/2 Unknown 120 enrolled Peking University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing eye health. A large number of epidemiological studies support the notion that the high intake dietary of lutein is strongly associated with a decreased relative risk of AMD.Moreover, findings from initial observational studies have now been followed by placebo-controlled intervention trials showing that dietary modification and supplementation with lutein result in increasing the macular pigment optical density, and may help to improve visual function in patients suffering from AMD.Currently, nutritional status and background information of lutein and zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy benefits of lutein on visual function in the AMD populations. In particular, the effect on visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on MPOD and visual function in AMD.

Timeline

Start
2009-09
Primary completion
2012-04
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lutein Other / unclassified 10 mg
Comparator Zeaxanthin Small molecule 10 mg