The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
研究概览
简要总结
This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High zeaxanthin
zeaxanthin group
干预措施: high zeaxanthin (Dietary Supplement)
Placebo
starch in hard shell gelatine capsules
干预措施: placebo (Dietary Supplement)
Low lutein
low lutein group
干预措施: low lutein (Dietary Supplement)
High lutein
high lutein group
干预措施: high lutein (Dietary Supplement)
Low lutein zeaxanthin
lutein plus zeaxanthin group
干预措施: lutein plus zeaxanthin (Dietary Supplement)
high lutein zeaxanthin
Zeaxanthin plus lutein group
干预措施: zeaxanthin plus lutein (Dietary Supplement)
结局指标
主要结局
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
时间窗: 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.
次要结局
- 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)
- Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention(at baseline, 24, 48 weeks and 2 years)
- 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 Serum Xanthophylls Concentrations During the Intervention(at baseline and 4, 12, 24 and 48 weeks 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 From Baseline in Microperimetry (MP) During the Intervention(at baseline, 24, 48 weeks and 2 years during the intervention)
研究者
Xiaoming Lin
Study Principal Investigator
Peking University