Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000114
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
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:
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa
Detailed Description:
Retinitis pigmentosa RP is a group of inherited retinal degenerations with a worldwide prevalence of about 1 in 4000 Patients typically report night blindness in adolescence and lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to progressive loss of both rod and cone function Most patients have reductions in central vision by age 50 to 80 years Modern-day electroretinograms ERGs make it possible to record retinal responses from most patients with remaining vision and thereby monitor objectively the course of their disease
While the natural course of retinal degeneration in the common forms of RP was being studied it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG amplitude over a 2-year period These preliminary findings as well as the known roles of vitamins A and E in maintaining normal photoreceptor function and structure prompted this randomized controlled trial to determine whether these vitamins alone or in combination would halt or slow the progression of the common forms of RP
This study was a randomized controlled double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years Patients were assigned to one of four treatment groups
15000 IUday vitamin A
15000 IUday vitamin A 400 IUday vitamin E
trace amounts of both vitamins A and E
400 IUday of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude In addition visual field and visual acuity were measured annually
While the natural course of retinal degeneration in the common forms of RP was being studied it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG amplitude over a 2-year period These preliminary findings as well as the known roles of vitamins A and E in maintaining normal photoreceptor function and structure prompted this randomized controlled trial to determine whether these vitamins alone or in combination would halt or slow the progression of the common forms of RP
This study was a randomized controlled double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years Patients were assigned to one of four treatment groups
15000 IUday vitamin A
15000 IUday vitamin A 400 IUday vitamin E
trace amounts of both vitamins A and E
400 IUday of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude In addition visual field and visual acuity were measured annually
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