Phase 3
N=240
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT00346333 ↗Enrolled (actual)
240
Serious AEs
0.8%
Results posted
Jan 2014
Primary outcome: Primary: Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA). — -51.5; -49.6 annual change in db vf sensitivity — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lutein (Drug); Cornstarch control (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Eye Institute (NEI)
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA). |
-51.5; -49.6 | 0.66 |
| SECONDARY Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer. |
-34.1; -26.6 | 0.05 |
| SECONDARY Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer. |
-83.1; -92.9 | 0.24 |
| SECONDARY Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period. |
-0.08; -0.09 | 0.59 |
| SECONDARY Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity |
-0.49; -0.53 | 0.80 |
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 = 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.
Data sourced from ClinicalTrials.gov (NCT00346333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.