Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346333
Status:
COMPLETED
Last Update Posted:
2014-01-31
First Post:
2006-06-27
Brief Title:
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Randomized Clinical Trial for Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4000 Patients typically report night blindness and difficulty with mid-peripheral visual field in adolescence As the condition progresses they lose far peripheral visual field Most patients have reductions in central vision by 60 years if left untreated Vitamin A palmitate 15000 International Units IUd and an omega-3 rich diet have been shown to slow the progression of this condition among adults with the typical formssee Archives of Ophthalmology111761-7721993 Archives of Ophthalmology 122 1306-1314 2004 Archives of Ophthalmology 1306701-7112013
The present study was a randomized controlled double-masked trial with a planned duration of 5 yearsTwo hundred and forty adults with the typical forms of RP were assigned to either lutein 12mgd or a control group Patients in both groups received 15000 IUday of vitamin A palmitate in addition to the supplement under study Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer HFA In additionthe total point score for the 60-4 program the total point score of the 30-2 and 60-4 programs combined computer-averaged 30-Hz cone Electroretinogram ERG amplitude and Early Treatment Diabetic Retinopathy Study ETDRS visual acuity were measured annually as secondary endpoints
The present study was a randomized controlled double-masked trial with a planned duration of 5 yearsTwo hundred and forty adults with the typical forms of RP were assigned to either lutein 12mgd or a control group Patients in both groups received 15000 IUday of vitamin A palmitate in addition to the supplement under study Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer HFA In additionthe total point score for the 60-4 program the total point score of the 30-2 and 60-4 programs combined computer-averaged 30-Hz cone Electroretinogram ERG amplitude and Early Treatment Diabetic Retinopathy Study ETDRS visual acuity were measured annually as secondary endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None