Status:
COMPLETED
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.
Detailed Description
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-perip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00346333
Start Date
July 1 2003
End Date
December 1 2008
Last Update
January 31 2014
Active Locations (1)
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1
Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114