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

March 15, 2012 updated by: Le MA, Peking University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

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

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group L20
Dietary Supplement: 20mg Lutein; daily supplementation one year
Dietary supplement: lutein
Dietary Supplement: 20mg Lutein; daily supplementation one year
Active Comparator: Group L10
Dietary Supplement: 10mg Lutein; daily supplementation one year
Dietary supplement: Lutein
Dietary Supplement: 10mg Lutein; daily supplementation one year
Placebo Comparator: Group Placebo
Dietary Supplement: Placebo, 0 mg Lutein
Dietary supplement: placebo
Dietary Supplement: placebo; daily supplementation one year
Active Comparator: Active Comparator: Group LZ
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
Drug: Lutein and zeaxanthin
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MPOD and multifocal electroretinograms
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Peking University

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

September 1, 2009

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC30872113

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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