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

Peking University

Status: Completed

Conditions: Age-related Macular Degeneration

Treatments: Dietary Supplement: zeaxanthin plus lutein; Dietary Supplement: lutein plus zeaxanthin; Dietary Supplement: high lutein; Dietary Supplement: high zeaxanthin; Dietary Supplement: low lutein; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01528605

NNSFC-30872113

Details and patient eligibility

About

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

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

starch in hard shell gelatine capsules

Treatment:

Dietary Supplement: placebo

Low lutein

Experimental group

Description:

low lutein group

Treatment:

Dietary Supplement: low lutein

High lutein

Experimental group

Description:

high lutein group

Treatment:

Dietary Supplement: high lutein

Low lutein zeaxanthin

Experimental group

Description:

lutein plus zeaxanthin group

Treatment:

Dietary Supplement: lutein plus zeaxanthin

High zeaxanthin

Experimental group

Description:

zeaxanthin group

Treatment:

Dietary Supplement: high zeaxanthin

high lutein zeaxanthin

Experimental group

Description:

Zeaxanthin plus lutein group

Treatment:

Dietary Supplement: zeaxanthin plus lutein