Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT00346333
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00346333
Study Brief:
Protocol Section:
NCT00346333