NCT01528605

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	placebo	Placebo, one gelatine capsule containing starch per day, for 96 weeks
DIETARY_SUPPLEMENT	low lutein	one gelatine capsule containing 10mg lutein per day, for 96 weeks
DIETARY_SUPPLEMENT	high lutein	one gelatine capsule containing 20mg lutein per day, for 96 weeks
DIETARY_SUPPLEMENT	lutein plus zeaxanthin	one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
DIETARY_SUPPLEMENT	high zeaxanthin	one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
DIETARY_SUPPLEMENT	zeaxanthin plus lutein	one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-02-08
• Last updated: 2014-08-29
• Results posted: 2014-08-29

Locations

1 site across 1 country: China