A Phase 1/2 interventional study of lutein and Lutein in Age-related Macular Degeneration, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by Peking University · Phase 1/2, Interventional, and Treatment
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 120 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
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Exclusion Criteria:
Dietary Supplement: 20mg Lutein; daily supplementation one year
Dietary Supplement: lutein
Dietary Supplement: 10mg Lutein; daily supplementation one year
Dietary Supplement: Lutein
Dietary Supplement: Placebo, 0 mg Lutein
Dietary Supplement: placebo
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
Drug: Lutein and zeaxanthin
Dietary Supplement: 20mg Lutein; daily supplementation one year
Dietary Supplement: 10mg Lutein; daily supplementation one year
Dietary Supplement: placebo; daily supplementation one year
Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
MPOD and multifocal electroretinograms
Time frame: 1 year
the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.
Time frame: 1 year
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Peking University