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

Primary Purpose

Age-related Macular Degeneration

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

lutein

Lutein

placebo

Lutein and zeaxanthin

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring AMD

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included)
Age between 50 and 90 years
Able to understand and comply with the requirements of the trial
Visual acuity > 0.4
Subjects must agree to take only the nutritional supplement that is

Exclusion Criteria:

Currently enrolled in an ophthalmic clinical trial
Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD
Eyes with a diagnosis of exudative AMD with active subretinal neovascularization (SRNV) or CNV lesions requiring laser photocoagulation in the study eye
Subjects with significant ocular lens opacities causing vision decrease
Subjects with amblyopia
Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mm Hg, 3 or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies
Subjects with demand type pacemakers or epilepsy
Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater)
Subjects with recent history (within the previous year) of cerebral vascular disease
manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's)
Subjects with a history of AIDS
lutein supplementation within the last 3 months
Subjects who have had intraocular surgery in trial eye within 3 months prior to enrolling in the trial
Patients who are unwilling to adhere to visit examination schedules

Sites / Locations

Peking universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Group L20

Group L10

Group Placebo

Active Comparator: Group LZ

Arm Description

Dietary Supplement: 20mg Lutein; daily supplementation one year

Dietary Supplement: 10mg Lutein; daily supplementation one year

Dietary Supplement: Placebo, 0 mg Lutein

Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

Outcomes

Primary Outcome Measures

MPOD and multifocal electroretinograms

Secondary Outcome Measures

the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.

Full Information

NCT ID

NCT01048476

First Posted

January 12, 2010

Last Updated

March 15, 2012

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01048476

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing eye health. A large number of epidemiological studies support the notion that the high intake dietary of lutein is strongly associated with a decreased relative risk of AMD.Moreover, findings from initial observational studies have now been followed by placebo-controlled intervention trials showing that dietary modification and supplementation with lutein result in increasing the macular pigment optical density, and may help to improve visual function in patients suffering from AMD.Currently, nutritional status and background information of lutein and zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy benefits of lutein on visual function in the AMD populations. In particular, the effect on visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on MPOD and visual function in AMD.

Detailed Description

We aim to study the effect and the mechanism of lutein in the prevention and treatment for age-related macular degeneration (AMD). Using the cluster sampling method, baseline characteristics screening will be performed in Han nationality men and women in the suburban areas of Beijing, ranging in age from 50 to79 years. According to clinical diagnosis standard of AMD, AMD (n=120) and normal subjects (n=40) will be randomly selected to measure serum lutein and nutritional status, and evaluate the relationship between lutein and AMD. Each subject of AMD will be randomly assigned to 1 of 4 groups: Group low lutein (Group LL); Group high lutein (Group HL); Group lutein/zeaxanthin (Group LZ); and Group Placebo to participate in the randomized, double-blind, placebo-controlled, 1 year intervention study, respectively. Macular pigment optical density,related symptoms and multifocal electroretinogram (mfERG) will be measured at at weeks 0, 24 and 48, to compare their dynamic changes in response to supplements at baseline and each follow-up visit, observe time- and dose-response correlation of supplementation with lutein, assess the efficacy, dosage of lutein and/or zeaxanthin supplement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group L20

Arm Type

Active Comparator

Arm Description

Dietary Supplement: 20mg Lutein; daily supplementation one year

Arm Title

Group L10

Arm Type

Active Comparator

Arm Description

Dietary Supplement: 10mg Lutein; daily supplementation one year

Arm Title

Group Placebo

Arm Type

Placebo Comparator

Arm Description

Dietary Supplement: Placebo, 0 mg Lutein

Arm Title

Active Comparator: Group LZ

Arm Type

Active Comparator

Arm Description

Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

Intervention Type

Dietary Supplement

Intervention Name(s)

lutein

Intervention Description

Dietary Supplement: 20mg Lutein; daily supplementation one year

Intervention Type

Dietary Supplement

Intervention Name(s)

Lutein

Intervention Description

Dietary Supplement: 10mg Lutein; daily supplementation one year

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

Dietary Supplement: placebo; daily supplementation one year

Intervention Type

Drug

Intervention Name(s)

Lutein and zeaxanthin

Intervention Description

Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

Primary Outcome Measure Information:

Title

MPOD and multifocal electroretinograms

Time Frame

1 year

Secondary Outcome Measure Information:

Title

the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included) Age between 50 and 90 years Able to understand and comply with the requirements of the trial Visual acuity > 0.4 Subjects must agree to take only the nutritional supplement that is Exclusion Criteria: Currently enrolled in an ophthalmic clinical trial Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD Eyes with a diagnosis of exudative AMD with active subretinal neovascularization (SRNV) or CNV lesions requiring laser photocoagulation in the study eye Subjects with significant ocular lens opacities causing vision decrease Subjects with amblyopia Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mm Hg, 3 or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies Subjects with demand type pacemakers or epilepsy Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater) Subjects with recent history (within the previous year) of cerebral vascular disease manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's) Subjects with a history of AIDS lutein supplementation within the last 3 months Subjects who have had intraocular surgery in trial eye within 3 months prior to enrolling in the trial Patients who are unwilling to adhere to visit examination schedules

Facility Information:

Facility Name

Peking university

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

le Ma, MD

male@bjmu.edu.cn

12. IPD Sharing Statement

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

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