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

Completed · Phase 3

Conditions studied: Retinitis Pigmentosa

In brief

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

Key facts

Study ID

NCT00346333

Run by

National Eye Institute (NEI)

People needed

240

Starts

2003-07-01

Expected to finish

2008-12-01

Last updated by the study team

2014-01-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.