Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000116
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
1999-09-23
Brief Title:
Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A
Sponsor:
Carol Weigel DiFranco
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Clinical Trial of Docosahexaenoic Acid DHA in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment
Status:
COMPLETED
Status Verified Date:
2023-02
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 a nutritional supplement 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 midperipheral visual field in adolescence As the condition progresses they lose far peripheral visual field Most patients have reductions in central vision by age 50 to 80 years Based on electroretinograms ERGs the course of the disease can be slowed on average among adults on 15000 IUday of vitamin A palmitate While conducting the trial on the effects of vitamin A on RP it became apparent that another substance in the diet could be affecting the course of the disease This prompted the present randomized controlled trial
This study is a randomized controlled double-masked trial with a planned duration of 5 years Patients with the common forms of RP are assigned to either a test or a control group All receive 15000 IUday of vitamin A palmitate in addition to either 1200 mgd of docosahexaenoic acid or control capsules Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial The main outcome measurement is the total point score on the Humphrey Field Analyzer HFA In addition computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually
This study is a randomized controlled double-masked trial with a planned duration of 5 years Patients with the common forms of RP are assigned to either a test or a control group All receive 15000 IUday of vitamin A palmitate in addition to either 1200 mgd of docosahexaenoic acid or control capsules Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial The main outcome measurement is the total point score on the Humphrey Field Analyzer HFA In addition computer-averaged 30-Hz cone ERG amplitudes and visual acuity are 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