The Influence of Lutein Supplements on Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Macular Pigment Optical Density
研究概览
简要总结
Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease.
Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions.
Study design: Randomized, double blind, placebo controlled intervention study.
Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AMD grade 2 or 3
- •visual acuity > 0.5
- •BMI < 30
排除标准
- •using lutein supplements
- •diseases that interfere with lipid absorption
- •other eye diseases
结局指标
主要结局
Macular Pigment Optical Density
时间窗: Baseline, 4 months, 8 months, 12 months
次要结局
- Visual Acuity(Baseline, 4 months, 8 months, 12 months)