Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Intervention: Lutein; Cornstarch control
Intervention description: 12mg/d; Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Retinitis Pigmentosa, Inherited Retinal Degeneration

Summary:

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

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.