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

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

placebo

low lutein

high lutein

lutein plus zeaxanthin

high zeaxanthin

zeaxanthin plus lutein

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring lutein, zeaxanthin, age-related macular degeneration, supplementation, macular pigment optical density, visual function, serum concentration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Haidian District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low lutein

High lutein

Low lutein zeaxanthin

High zeaxanthin

high lutein zeaxanthin

Arm Description

starch in hard shell gelatine capsules

low lutein group

high lutein group

lutein plus zeaxanthin group

zeaxanthin group

Zeaxanthin plus lutein group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Changes of Contrast Sensitivity (CSF) Measured by CSV-100 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

Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks

Changes From Baseline in Microperimetry (MP) During the Intervention

Microperimetry (MP) was measured by the MP1 Microperimeter

Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention

Full Information

NCT ID

NCT01528605

First Posted

December 28, 2011

Last Updated

August 18, 2014

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01528605

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

December 2012 (Actual)

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

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.

6. Conditions and Keywords

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

Age-related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

starch in hard shell gelatine capsules

Arm Title

Low lutein

Arm Type

Experimental

Arm Description

low lutein group

Arm Title

High lutein

Arm Type

Experimental

Arm Description

high lutein group

Arm Title

Low lutein zeaxanthin

Arm Type

Experimental

Arm Description

lutein plus zeaxanthin group

Arm Title

High zeaxanthin

Arm Type

Experimental

Arm Description

zeaxanthin group

Arm Title

high lutein zeaxanthin

Arm Type

Experimental

Arm Description

Zeaxanthin plus lutein group

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

low lutein

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

high lutein

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

lutein plus zeaxanthin

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

high zeaxanthin

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

zeaxanthin plus lutein

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years

Description

Time Frame

at baseline and 24 weeks, 48 weeks, 2 years during the intervention

Secondary Outcome Measure Information:

Title

Changes of Serum Xanthophylls Concentrations During the Intervention

Description

Time Frame

at baseline and 4, 12, 24 and 48 weeks during the intervention

Title

Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention

Description

Time Frame

at baseline and 24 weeks, 48 weeks, 2 years during the intervention

Title

Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention

Time Frame

at baseline, 24, 48 weeks and 2 years during the intervention

Title

Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer

Description

Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks

Time Frame

at baseline, 24, 48 weeks and 2 years during the intervention

Title

Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks

Time Frame

at baseline and 48 weeks during the intervention

Title

Changes From Baseline in Microperimetry (MP) During the Intervention

Description

Microperimetry (MP) was measured by the MP1 Microperimeter

Time Frame

at baseline, 24, 48 weeks and 2 years during the intervention

Title

Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention

Time Frame

at baseline, 24, 48 weeks and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoming Lin, M.M.

Organizational Affiliation

Peking University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haidian District

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22835510

Citation

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.

Results Reference

derived

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

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