Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065455
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-07-23
Brief Title:
Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study on the Effect of Vitamin A Supplementation on Cone Function in Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2009-05-06
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:
Retinitis pigmentosa RP is a collective term for a group of inherited retinal dystrophies that are a major cause of irreversible blindness RP of some type occurs in approximately 1 out of 3500 persons in the United States1 Gene mutations are responsible for the majority of RP To date mutations have been identified in 30 different genes linked to RP2 The visual prognosis of RP is poor since the gradual but relentless visual field loss leads eventually to some degree of blindness3 Although no effective treatment for RP has been identified participants supplemented with a daily oral dose of 15000 IU vitamin A palmitate have shown on average a slower rate of deterioration of retinal function when the intervention is continued over several years4 The purpose of this research is to determine whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor function in RP participants as measured by electroretinography ERG In this interventional non-randomized prospective pilot study 5 participants will receive a daily oral dose of 50000 IU of vitamin A palmitate for 4 weeks followed by a maintenance dose of 15000 IU daily for the subsequent 2 weeks The primary efficacy outcome is a relative percentage change in ERG response amplitude subsequent to vitamin A supplementation A secondary efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin A supplementation with improvement specified as a shorter response implicit time Other secondary outcomes will be improvements in visual field Humphery 10-2 sum of thresholds Safety outcomes include visual fields ETDRS visual acuity intraocular pressure serum vitamin A level and liver function tests
Detailed Description:
Retinitis pigmentosa RP is a collective term for a group of inherited retinal dystrophies that are a major cause of irreversible blindness RP of some type occurs in approximately 1 out of 3500 persons in the United States Gene mutations are responsible for the majority of RP To date mutations have been identified in 30 different genes linked to RP The visual prognosis of RP is poor since the gradual but relentless visual field loss leads eventually to some degree of blindness Although no effective treatment for RP has been identified participants supplemented with a daily oral dose of 15000 IU vitamin A palmitate have shown on average a slower rate of deterioration of retinal function when the intervention is continued over several years The purpose of this research is to determine whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor function in RP participants as measured by electroretinography ERG In this interventional non-randomized prospective pilot study 10 participants five with the RHO1 gene mutation and five without the mutation will receive a daily oral dose of 50000 IU of vitamin A palmitate for 4 weeks followed by a maintenance dose of 15000 IU daily for the subsequent 2 weeks The primary efficacy outcome is a relative percentage change in ERG response amplitude subsequent to vitamin A supplementation A secondary efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin A supplementation with improvement specified as a shorter response implicit time Other secondary outcomes will be improvements in visual field Humphrey 10-2 sum of thresholds Safety outcomes include visual fields ETDRS visual acuity intraocular pressure serum vitamin A level and liver function tests
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-EI-0255 | None | None | None |