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

August 18, 2014 updated by: Xiaoming Lin, Peking University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Haidian District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
Time Frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention

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
Time Frame: at baseline and 4, 12, 24 and 48 weeks 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
Time Frame: at baseline and 24 weeks, 48 weeks, 2 years 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
Time Frame: at baseline, 24, 48 weeks and 2 years 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
Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention
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
Time Frame: at baseline and 48 weeks during the intervention
at baseline and 48 weeks during the intervention
Changes From Baseline in Microperimetry (MP) During the Intervention
Time Frame: at baseline, 24, 48 weeks and 2 years 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
Time Frame: at baseline, 24, 48 weeks and 2 years
at baseline, 24, 48 weeks and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Xiaoming Lin, M.M., Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 28, 2011

First Submitted That Met QC Criteria

February 4, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNSFC-30872113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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