Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Typical duration for phase_1
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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 16, 2012
March 1, 2012
2.6 years
January 12, 2010
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MPOD and multifocal electroretinograms
1 year
Secondary Outcomes (1)
the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.
1 year
Study Arms (4)
Group L20
ACTIVE COMPARATORDietary Supplement: 20mg Lutein; daily supplementation one year
Group L10
ACTIVE COMPARATORDietary Supplement: 10mg Lutein; daily supplementation one year
Group Placebo
PLACEBO COMPARATORDietary Supplement: Placebo, 0 mg Lutein
Active Comparator: Group LZ
ACTIVE COMPARATORDietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
Interventions
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking university
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PMID: 37702300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MAL
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 13, 2010
Study Start
September 1, 2009
Primary Completion
April 1, 2012
Study Completion
October 1, 2012
Last Updated
March 16, 2012
Record last verified: 2012-03