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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: placebo
* Dietary Supplement: low lutein
* Dietary Supplement: high lutein
* Dietary Supplement: lutein plus zeaxanthin
* Dietary Supplement: high zeaxanthin
* Dietary Supplement: zeaxanthin plus lutein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>starch in hard shell gelatine capsules | Dietary Supplement: placebo<br>* Placebo, one gelatine capsule containing starch per day, for 96 weeks<br>|
| Experimental: Low lutein<br>low lutein group | Dietary Supplement: low lutein<br>* one gelatine capsule containing 10mg lutein per day, for 96 weeks<br>|
| Experimental: High lutein<br>high lutein group | Dietary Supplement: high lutein<br>* one gelatine capsule containing 20mg lutein per day, for 96 weeks<br>|
| Experimental: Low lutein zeaxanthin<br>lutein plus zeaxanthin group | Dietary Supplement: lutein plus zeaxanthin<br>* one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks<br>|
| Experimental: High zeaxanthin<br>zeaxanthin group | Dietary Supplement: high zeaxanthin<br>* one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks<br>|
| Experimental: high lutein zeaxanthin<br>Zeaxanthin plus lutein group | Dietary Supplement: zeaxanthin plus lutein<br>* one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at baseline and 24 weeks, 48 weeks, 2 years during the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at baseline and 24 weeks, 48 weeks, 2 years during the intervention | 
| Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention |  | at baseline, 24, 48 weeks and 2 years during the intervention | 
| Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer | Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks | at baseline, 24, 48 weeks and 2 years during the intervention | 
| Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks |  | at baseline and 48 weeks during the intervention | 
| Changes From Baseline in Microperimetry (MP) During the Intervention | Microperimetry (MP) was measured by the MP1 Microperimeter | at baseline, 24, 48 weeks and 2 years during the intervention | 
| Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention |  | at baseline, 24, 48 weeks and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lutein, zeaxanthin, age-related macular degeneration, supplementation, macular pigment optical density, visual function, serum concentration