跳至主要内容
临床试验/NCT01042860
NCT01042860已完成不适用

The Influence of Lutein Supplements on Age-related Macular Degeneration

Maastricht University Medical Center4 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2007年8月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (4)

Loading locations...

相似试验