Lutein Influence on Macula of Persons Issued From Amd Parents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation
研究概览
简要总结
Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.
详细描述
The objective of this study is to estimate the efficiency of a nutritonal supplementation with lutein and zeaxanthin to increase their plasma concentration and the density of macular pigment, in subjects at high genetic risk for AMD (1st generation stemming from parent affected by DMLA). This study is a multicentric, double blind, randomized clinical trial of supplementation versus placebo
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 40 to 70 years old
- •Presenting histories of wet AMD with their father or their mother or 2
- •Visual acuity of 20/25 or better (ETDRS)
- •The presence of a AMD in one eye is possible
- •Enlightened consent writes, dated and signed by the participant and the investigator above all examination required by the research.
- •Subject agreeing to be registered in the national file
- •Affiliated or profitable subject of a national insurance scheme
排除标准
- •Presence of signs of AMD in both eyes (if AMD in one eye, inclusion for the other eye is possible)
- •Histories of the other evolutionary eye pathologies susceptible to complicate the evaluation of the AMD and of the visual acuity (severe glaucoma, strong nearsightedness (superior or more equal in - 6 dioptres), the other severe rétinopathie)
- •Subject with history of cataract surgery
- •Opaqueness preventing the evaluation of the photos of the retina (cataract, corneal dystrophy)
- •Supplementation with food complements in the year which precedes (cf. appendix 2 of the protocol)
- •Participation in another clinical trial during 30 days which precede
- •Subjects not compliants
- •Subjects not flatware by the system of social security
- •Subjects under guardianship judicial
结局指标
主要结局
The main assessment criterion is the measure of the evolution of the density of the macular pigment after 6 months of supplementation
时间窗: 6 months after stop of the supplementation
Difference in measures of the density of the macular pigment at baseline and 6 months after stop of the supplementation
次要结局
- Measure of the modification of the visual acuteness with correction(12 months)
- Measure of the cognitive capacities(12 months)
- Measure rates plasmatiques of fatty acids(12 months)
- Measure of the evolution of the density of the macular pigment during supplementation and after stop of the supplementation(1 year)