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

NCT01048476 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-03-16

No results posted yet for this study

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.

Conditions

  • Age-related Macular Degeneration

Interventions

DIETARY_SUPPLEMENT

lutein

Dietary Supplement: 20mg Lutein; daily supplementation one year

DIETARY_SUPPLEMENT

Lutein

Dietary Supplement: 10mg Lutein; daily supplementation one year

DIETARY_SUPPLEMENT

placebo

Dietary Supplement: placebo; daily supplementation one year

DRUG

Lutein and zeaxanthin

Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-04-30
Completion
2012-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048476 on ClinicalTrials.gov