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NCT01528605

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

NCT ID: NCT01528605

Last Updated: 2014-08-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

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.

Conditions

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Age-related Macular Degeneration

Keywords

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lutein zeaxanthin age-related macular degeneration supplementation macular pigment optical density visual function serum concentration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

starch in hard shell gelatine capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo, one gelatine capsule containing starch per day, for 96 weeks

Low lutein

low lutein group

Group Type EXPERIMENTAL

low lutein

Intervention Type DIETARY_SUPPLEMENT

one gelatine capsule containing 10mg lutein per day, for 96 weeks

High lutein

high lutein group

Group Type EXPERIMENTAL

high lutein

Intervention Type DIETARY_SUPPLEMENT

one gelatine capsule containing 20mg lutein per day, for 96 weeks

Low lutein zeaxanthin

lutein plus zeaxanthin group

Group Type EXPERIMENTAL

lutein plus zeaxanthin

Intervention Type DIETARY_SUPPLEMENT

one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks

High zeaxanthin

zeaxanthin group

Group Type EXPERIMENTAL

high zeaxanthin

Intervention Type DIETARY_SUPPLEMENT

one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks

high lutein zeaxanthin

Zeaxanthin plus lutein group

Group Type EXPERIMENTAL

zeaxanthin plus lutein

Intervention Type DIETARY_SUPPLEMENT

one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks

Interventions

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placebo

Placebo, one gelatine capsule containing starch per day, for 96 weeks

Intervention Type DIETARY_SUPPLEMENT

low lutein

one gelatine capsule containing 10mg lutein per day, for 96 weeks

Intervention Type DIETARY_SUPPLEMENT

high lutein

one gelatine capsule containing 20mg lutein per day, for 96 weeks

Intervention Type DIETARY_SUPPLEMENT

lutein plus zeaxanthin

one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks

Intervention Type DIETARY_SUPPLEMENT

high zeaxanthin

one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks

Intervention Type DIETARY_SUPPLEMENT

zeaxanthin plus lutein

one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoming Lin

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoming Lin, M.M.

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

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Haidian District

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED

PMID: 22835510 (View on PubMed)

Other Identifiers

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NNSFC-30872113

Identifier Type: -

Identifier Source: org_study_id