Skip to main content
OpenTrials
Completed

NCT Number: NCT01528605

Effects of Lutein and Zeaxanthin Supplementation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haidian District

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

low lutein

Dietary Supplement

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

high lutein

Dietary Supplement

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

lutein plus zeaxanthin

Dietary Supplement

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

high zeaxanthin

Dietary Supplement

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

zeaxanthin plus lutein

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

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

    Time frame: at baseline and 48 weeks during the intervention

  6. 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

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

    Time frame: at baseline, 24, 48 weeks and 2 years

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.