Randomized Clinical Trial for Retinitis Pigmentosa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).
研究概览
简要总结
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.
详细描述
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with mid-peripheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by 60 years if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an omega-3 rich diet have been shown to slow the progression of this condition among adults with the typical forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of Ophthalmology 122: 1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013).
The present study was a randomized, controlled, double-masked trial with a planned duration of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin A palmitate in addition to the supplement under study. Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial. The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point score of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram (ERG) amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were measured annually as secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular Criteria
- •RP, typical forms(i.e. elevated final dark adaptation threshold,retinal arteriolar narrowing,and reduced and delayed full-field ERGs).
- •Best-corrected visual acuity 20/100 or better
- •HFA program 30-2 total point score >= 250 decibels(dB)to a size V white test light
- •No confounding ocular disease such as glaucoma,uveitis,diabetic retinopathy,posterior subcapsular cataract more than 11% of total lens area (ie equivalent to P3 on Lens Opacity Classification System III)and pupil diameter after dilation less than 6 mm.
- •Dietary Criteria
- •Fruit and vegetable intake < 10 servings/d
- •Spinach or kale intake < 1 serving/d, i.e. <1/2 cup of cooked spinach or kale per day
- •Dietary lutein intake <=5.4 mg/d as estimated from food frequency questionnaire
- •No intake of cod liver oil or omega-3 capsules
- •Dietary preformed vitamin A intake <= 10,000 IU/d
- •Supplement intake <= 5,000 IU/d of Vitamin A and <= 30 IU/d of Vitamin E
- •Consumption <= 3 alcoholic beverages/d
- •Medical and other criteria
- •Age 18-60 y
- •Body mass index < 40 and weight >= 5th percentile for age,gender,and height
- •Serum retinol level <= 100 micrograms/deciliter and serum retinyl ester level <= 380 nanomoles/Liter
- •Serum cholesterol < 300 micrograms/deciliter and serum triglyceride level <400 micrograms/deciliter
- •No clinically significant abnormality on blood cell count, glucose level, blood urea nitrogen level, serum lipid panel results or serum liver function profile.
- •Not pregnant or planning to become pregnant
- •Not smoking currently
- •Agreed not to know tablet content or course of condition until the end of the trial.
- •No other disease which might affect absorption or metabolism of lutein or vitamin A.
- •Only one patient per family was accepted into the study.
排除标准
- •Women who are pregnant or planning to become pregnant (Vitamin A supplements can increase the risk of birth defects.)
- •Current participation in another clinical trial for RP
- •Patients with atypical forms such as paravenous RP, pericentral RP, sector RP,unilateral RP,Refsum disease, Bardet-Biedl syndrome, retinitis punctata albescens and cone-rod dystrophy were excluded as were patients with RP and profound congenital deafness.
研究组 & 干预措施
Lutein plus 15,000 IU/d Vitamin A
Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate
干预措施: Lutein (Drug)
Control plus 15,000 IU/d Vitamin A
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
干预措施: Cornstarch control (Dietary Supplement)
结局指标
主要结局
Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).
时间窗: assessed at each of 4 annual visits after baseline
Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.
次要结局
- Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.(assessed at each of 4 annual visits after baseline)
- Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.(assessed at each of 4 annual visits after baseline)
- Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity(assessed at each of 4 annual visits after baseline)
- Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.(assessed at each of 4 annual visits after baseline)