Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration
1 other identifier
interventional
168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 29, 2014
CompletedAugust 29, 2014
August 1, 2014
2.3 years
December 28, 2011
July 20, 2014
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Secondary Outcomes (7)
Changes of Serum Xanthophylls Concentrations During the Intervention
at baseline and 4, 12, 24 and 48 weeks during the intervention
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention
at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Changes of Contrast Sensitivity (CSF) Measured by CSV-100 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
at baseline, 24, 48 weeks and 2 years during the intervention
Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks
at baseline and 48 weeks during the intervention
- +2 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORstarch in hard shell gelatine capsules
Low lutein
EXPERIMENTALlow lutein group
High lutein
EXPERIMENTALhigh lutein group
Low lutein zeaxanthin
EXPERIMENTALlutein plus zeaxanthin group
High zeaxanthin
EXPERIMENTALzeaxanthin group
high lutein zeaxanthin
EXPERIMENTALZeaxanthin plus lutein group
Interventions
Placebo, one gelatine capsule containing starch per day, for 96 weeks
one gelatine capsule containing 10mg lutein per day, for 96 weeks
one gelatine capsule containing 20mg lutein per day, for 96 weeks
one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haidian District
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
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.
PMID: 22835510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Xiaoming Lin
- Organization
- Peking University
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoming Lin, M.M.
Peking University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
December 28, 2011
First Posted
February 8, 2012
Study Start
June 1, 2010
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
August 29, 2014
Results First Posted
August 29, 2014
Record last verified: 2014-08