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NCT00100230 · ClinicalTrials.gov registry record · Phase 2
DHA and X-Linked Retinitis Pigmentosa
A Phase 2 study, sponsored by Retina Foundation of the Southwest.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00100230: Completed Phase 2 study, sponsored by Retina Foundation of the Southwest.
NCT00100230 is a Phase 2 study that has completed, run by Retina Foundation of the Southwest. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00100230, a Phase 2 study, has completed, sponsored by Retina Foundation of the Southwest.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
Purpose: Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to specific genetic mutations. This trial is focused on patients with one of the most severe forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early onset (typically loss of night vision as a child) followed by loss of peripheral vision as a teenager and young adult. There is no male-to-male transmission of the disease in the family. There is no cure for RP and treatment options are limited. Two clinical trials have not found a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid, docosahexaenoic acid (DHA), at low daily doses although there is evidence that it slows disease progression in certain instances. In this clinical trial, we propose that a high dose nutritional DHA supplement will slow the loss of visual function and preserve usable vision in patients with XLRP. This study is a 4-year placebo-controlled randomized clinical trial meaning that patients have a 50-50 chance of receiving placebo or experimental treatment. A total of 66 patients will be enrolled; 33 will receive placebo and 33 will receive the treatment. Entry criteria include diagnosis of XLRP by an ophthalmologist, age 7 to 32 years, male, sufficient visual function such that disease progression can be followed for the entire duration of the trial, and a willingness to visit the testing site (Dallas, TX) once a year. Annual visual function testing includes ETDRS visual acuity, full-field and multifocal electroretinography (ERG), static peripheral visual fields, and fundus photography. Cone ERG function is the primary outcome measure. Funding Source - FDA, Foundation Fighting Blindness, DSM Nutritionals
Primary Outcome
Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.
Interventions
- DRUG docosahexaenoic acid OR corn/soy oil placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2004-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT00100230 record still lists
NCT00100230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 1 intervention - of which docosahexaenoic acid OR corn/soy oil placebo is the first listed.
NCT00100230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00100230 about?
NCT00100230 is a clinical study titled "DHA and X-Linked Retinitis Pigmentosa". Purpose: Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to specific genetic mutations. This trial is focused on patients with one of the most severe forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early onset (typically los...
What is the current status of trial NCT00100230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2004-09. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00100230?
The interventions under investigation include: docosahexaenoic acid OR corn/soy oil placebo (DRUG).
Who is sponsoring clinical trial NCT00100230?
This trial is sponsored by Retina Foundation of the Southwest, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00100230's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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