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This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | starch in hard shell gelatine capsules |
|
| Low lutein | Experimental | low lutein group |
|
| High lutein | Experimental | high lutein group |
|
| Low lutein zeaxanthin | Experimental | lutein plus zeaxanthin group |
|
| High zeaxanthin | Experimental | zeaxanthin group |
|
| high lutein zeaxanthin | Experimental | Zeaxanthin plus lutein group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Dietary Supplement | Placebo, one gelatine capsule containing starch per day, for 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Serum Xanthophylls Concentrations 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Lin, M.M. | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haidian District | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22835510 | Derived | 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. |
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We added "High Zeaxanthin" and "High Lutein Zeaxanthin" Arms at the seconde year for additional information on the effect of zeaxanthin on MPOD and visual functions. Therefore, we did not measure the changes of serum concentration, and only measured the change of MOPD and visual functions at baseline and 48 weeks, in the two new groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Lutein | low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks |
| FG001 | Placebo | starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks |
| FG002 | High Lutein | high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks |
| FG003 | Low Lutein Zeaxanthin | lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks |
| FG004 | High Zeaxanthin | zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks |
| FG005 | High Lutein Zeaxanthin | Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
4 participants was excluded during the analysis since they did not finish the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Lutein | low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks |
| BG001 | Placebo | starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | density units | at baseline and 24 weeks, 48 weeks, 2 years during the intervention |
|
2 years, and ask for notable adverse effects for an average interval of 1 month.
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. Subjects were encouraged to report any adverse effects immediately, and were asked specifically about adverse events such as carotenoderma every month during visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Lin | Peking University | 010-82805336 | linbjmu@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| 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 |
|
| at baseline and 4, 12, 24 and 48 weeks during the intervention |
| Changes of Best-spectacle Corrected Visual Acuity (BSCVA) 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. | 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 | Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks | 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 |
| Changes From Baseline in Microperimetry (MP) During the Intervention | Microperimetry (MP) was measured by the MP1 Microperimeter | at baseline, 24, 48 weeks and 2 years during the intervention |
| Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention | at baseline, 24, 48 weeks and 2 years |
| Death |
|
| BG002 | High Lutein | high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks |
| BG003 | Low Lutein Zeaxanthin | lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks |
| BG004 | High Zeaxanthin | zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks |
| BG005 | High Lutein Zeaxanthin | Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Low Lutein |
low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks |
| OG002 | High Lutein | high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks |
| OG003 | Low Lutein Zeaxanthin | lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks |
| OG004 | High Zeaxanthin | zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks |
| OG005 | High Lutein Zeaxanthin | Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks |
|
|
|
| Secondary | Changes of Serum Xanthophylls Concentrations 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. | Posted | Mean | Standard Deviation | μmol/L | at baseline and 4, 12, 24 and 48 weeks during the intervention |
|
|
|
|
| Secondary | Changes of Best-spectacle Corrected Visual Acuity (BSCVA) 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. | Posted | Mean | Standard Deviation | letters | at baseline and 24 weeks, 48 weeks, 2 years during the intervention |
|
|
|
|
| Secondary | Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention | Not Posted | Dec 2015 | at baseline, 24, 48 weeks and 2 years during the intervention |
| Secondary | Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer | Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks | Not Posted | Dec 2015 | at baseline, 24, 48 weeks and 2 years during the intervention |
| Secondary | Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks | Not Posted | Dec 2015 | at baseline and 48 weeks during the intervention |
| Secondary | Changes From Baseline in Microperimetry (MP) During the Intervention | Microperimetry (MP) was measured by the MP1 Microperimeter | Not Posted | Dec 2015 | at baseline, 24, 48 weeks and 2 years during the intervention |
| Secondary | Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention | Not Posted | Dec 2015 | at baseline, 24, 48 weeks and 2 years |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Low Lutein | low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks | 0 | 26 | 0 | 26 |
| EG002 | High Lutein | high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks | 0 | 27 | 0 | 27 |
| EG003 | Low Lutein Zeaxanthin | lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks | 0 | 27 | 0 | 27 |
| EG004 | High Zeaxanthin | zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks | 0 | 28 | 0 | 28 |
| EG005 | High Lutein Zeaxanthin | Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks | 0 | 28 | 0 | 28 |
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| 4 weeks |
|
| 12 weeks |
|
| 24 weeks |
|
| 48 weeks |
|
| 24 weeks |
|
| 48 weeks |
|
| 2 years |
|