Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Eye Institute (NEI)
• Treatments: Retinol palmitate; Vitamin A; Vitamin D; Vitamins

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.