Clinical trial NCT01528605: Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
Official title: The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: lutein
zeaxanthin
age-related macular degeneration
supplementation
macular pigment optical density
visual function
serum concentration
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 168
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
timeFrame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Secondary outcomes:
measure: Changes of Serum Xanthophylls Concentrations During the Intervention
timeFrame: at baseline and 4, 12, 24 and 48 weeks during the intervention
measure: Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention
timeFrame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention
measure: Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention
timeFrame: at baseline, 24, 48 weeks and 2 years during the intervention
measure: Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer
timeFrame: at baseline, 24, 48 weeks and 2 years during the intervention
measure: Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks
timeFrame: at baseline and 48 weeks during the intervention
measure: Changes From Baseline in Microperimetry (MP) During the Intervention
timeFrame: at baseline, 24, 48 weeks and 2 years during the intervention
measure: Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
timeFrame: at baseline, 24, 48 weeks and 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Haidian District
state: Beijing
Study officials:
affiliation: Peking University
name: Xiaoming Lin, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma L, Dou HL, Huang YM, Lu XR, Xu XR, Qian F, Zou ZY, Pang HL, Dong PC, Xiao X, Wang X, Sun TT, Lin XM. Improvement of retinal function in early age-related macular degeneration after lutein and zeaxanthin supplementation: a randomized, double-masked, placebo-controlled trial. Am J Ophthalmol. 2012 Oct;154(4):625-634.e1. doi: 10.1016/j.ajo.2012.04.014. Epub 2012 Jul 25.