Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004827
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Docosahexaenoic Acid DHA Supplementation in Patients With X-Linked Retinitis Pigmentosa
Sponsor:
Retina Foundation of the Southwest
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-05
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:
OBJECTIVES
I Evaluate the potential of nutritional docosahexaenoic acid DHA supplementation to normalize the level of DHA in red blood cells and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa
I Evaluate the potential of nutritional docosahexaenoic acid DHA supplementation to normalize the level of DHA in red blood cells and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa
Detailed Description:
PROTOCOL OUTLINE This is a randomized parallel double blind study Patients receive 2 gel capsules per day of either docosahexaenoic acid DHA enriched oil or a placebo oil Oral DHA supplementation continues daily for 3 years
All patients are followed every 6 months for the 3 year duration of the study
Completion date provided represents the completion date of the grant per OOPD records
All patients are followed every 6 months for the 3 year duration of the study
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RFS-FDR001232 | None | None | None |