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NCT00065455 · ClinicalTrials.gov registry record · Phase 1
Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa
A Phase 1 study of Retinitis Pigmentosa, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT00065455: Completed Phase 1 study of Retinitis Pigmentosa, sponsored by National Eye Institute (NEI).
NCT00065455 is a Phase 1 study of Retinitis Pigmentosa that has completed, run by National Eye Institute (NEI). The registered enrollment target is 11 participants, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065455, a Phase 1 study of Retinitis Pigmentosa, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study 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 States(1). Gene mutations are responsible for the majority of RP. To date, mutations have been identified in 30 different genes linked to RP(2). The visual prognosis of RP is poor, since the gradual but relentless visual field loss leads eventually to some degree of blindness(3). Although no effective treatment for RP has been identified, participants supplemented with a daily oral dose of 15,000 IU vitamin A palmitate have shown, on average, a slower rate of deterioration of retinal function when the intervention is continued over several years(4). 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 50,000 IU of vitamin A palmitate for 4 weeks, followed by a maintenance dose of 15,000 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.
Conditions Studied
Interventions
- DRUG Vitamin A
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2003-07-17 |
| Est. Completion | 2009-05-06 |
| Phase | Phase 1 |
What the finished NCT00065455 record still lists
NCT00065455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which Vitamin A is the first listed.
NCT00065455 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00065455 about?
NCT00065455 is a clinical study titled "Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa". 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(1). Gene mutations are responsible for the majority of RP. To date, mutatio...
What is the current status of trial NCT00065455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2003-07-17. Estimated completion is 2009-05-06.
What conditions does trial NCT00065455 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa.
What interventions are being tested in trial NCT00065455?
The interventions under investigation include: Vitamin A (DRUG).
Who is sponsoring clinical trial NCT00065455?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00065455 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00065455's enrollment target sits among peer trials
11 34th of 37 higher than 4 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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