Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Retinitis Pigmentosa
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Inherited Retinal Degeneration
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lutein plus 15,000 IU/d Vitamin A
Control plus 15,000 IU/d Vitamin A
Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate