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

Peking University168 enrolled

Overview

This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.

Early age-related macular degeneration (AMD) is an early hallmark of irreversible vision impairment accompanying with senescence of macular. Given the fact in treatment, prevention strategy is thought to be an efficient and robust approach to diminish early AMD patients in low-income countries, however, feasible cocktail provision in most developing nations remain mysteries. Here we proposed an effective cocktail treatment with different amounts of lutein and zeaxanthin could increase the macular pigment optical density (MPOD) and serum xanthophylls concentrations among randomized Chinese AMD patients; and might improve visual function measured by visual performance indices such as best-spectacle corrected visual acuity (BSCVA), contrast sensitivity (CSF), flash recovery time (FRT), multifocal electroretinogram (mfERG) and microperimetry.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

168

Conditions

Age-related Macular Degeneration

Interventions

placeboDIETARY_SUPPLEMENT

Placebo, one gelatine capsule containing starch per day, for 96 weeks

low luteinDIETARY_SUPPLEMENT

one gelatine capsule containing 10mg lutein per day, for 96 weeks

high luteinDIETARY_SUPPLEMENT

one gelatine capsule containing 20mg lutein per day, for 96 weeks

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * aged over 50 years, Chinese of the Han nationality * diagnosed as age-related macular degeneration * did not take lutein or zeaxanthin supplements in the past half a year * good general health * corrected visual acuity above 0.25 (20/80) * did not take optical laser or medical treatments Exclusion Criteria: * had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc. * had nervous system diseases, stroke, Type I diabetes * had diseases effected nutrients absorption, such as Crohn' s disease * had turbid ocular media or transplanted intraocular lenses * reported abnormal digestive condition

Locations (1)

Haidian District

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years

Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values. 4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.

Time frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention

Secondary Outcomes

Changes of Serum Xanthophylls Concentrations During the Intervention

Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.

Time frame: at baseline and 4, 12, 24 and 48 weeks during the intervention

Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention

best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.

Time frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention

Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention

Time frame: at baseline, 24, 48 weeks and 2 years during the intervention

Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer

Data from ClinicalTrials.gov

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