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

Not Applicable

Completed

Conditions: Age-related Macular Degeneration

Interventions: Dietary Supplement: placebo
Dietary Supplement: low lutein
Dietary Supplement: lutein plus zeaxanthin
Dietary Supplement: high lutein
Dietary Supplement: high zeaxanthin
Dietary Supplement: zeaxanthin plus lutein

Registration Number: NCT01528605

Lead Sponsor: Peking University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 168

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	starch in hard shell gelatine capsules
Low lutein	low lutein	low lutein group
Low lutein zeaxanthin	lutein plus zeaxanthin	lutein plus zeaxanthin group
High lutein	high lutein	high lutein group
High zeaxanthin	high zeaxanthin	zeaxanthin group
high lutein zeaxanthin	zeaxanthin plus lutein	Zeaxanthin plus lutein group

Primary Outcome Measures

Name	Time	Method
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years	at baseline and 24 weeks, 48 weeks, 2 years during the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer	at baseline, 24, 48 weeks and 2 years during the intervention	Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks
Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks	at baseline and 48 weeks during the intervention
Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention	at baseline, 24, 48 weeks and 2 years
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention	at baseline and 24 weeks, 48 weeks, 2 years 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.
Changes of Serum Xanthophylls Concentrations During the Intervention	at baseline and 4, 12, 24 and 48 weeks 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.
Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention	at baseline, 24, 48 weeks and 2 years during the intervention
Changes From Baseline in Microperimetry (MP) During the Intervention	at baseline, 24, 48 weeks and 2 years during the intervention	Microperimetry (MP) was measured by the MP1 Microperimeter