Status:
COMPLETED
DHA and X-Linked Retinitis Pigmentosa
Lead Sponsor:
Retina Foundation of the Southwest
Collaborating Sponsors:
Foundation Fighting Blindness
DSM Nutritional Products, Inc.
Conditions:
Retinitis Pigmentosa
X-linked Genetic Diseases
Eligibility:
MALE
7-32 years
Phase:
PHASE2
Brief 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 th...
Detailed Description
Location \& Contact Information: Retina Foundation of the Southwest, 9600 N. Central Expressway, Suite 200, Dallas, TX 75231 Contact: Dr. D. Hoffman (dhoffman@retinafoundation.org) or Dr. D. Birch (d...
Eligibility Criteria
Inclusion
- Diagnosis of RP by a retinal specialist
- Clinical diagnosis consistent with X-linked inheritance
- Enrolling minors and young adults (early onset of X-linked disease; ages 7 to 32)
- Measurable cone ERG responses --patients with less than 0.64 microvolt response to 31-Hz flicker will be excluded as they are more likely to become undetectable during the study
- Both eyes must meet entry criteria as both will be tested (i.e., no cataracts requiring surgery or retinal detachments).
- Media clarity sufficient for fundus photography
- Able to return to study site at yearly intervals
- Willing to supply blood samples at 6-month intervals
- Judiciously take the placebo or DHA supplement for the 4-year study duration
- Patient/parent/guardian understands and signs consent form.
Exclusion
- Excessive fish consumption (e.g., cold water fish such as salmon, tuna, sardines) and/or fish oil supplementation (or other oil containing DHA)
- Baseline RBC-DHA levels showing evidence of supplementation (a typical level of RBC-DHA in normals is about 3.8%)
- Chronic metabolic disease that may interfere with fatty acid metabolism or require anti-coagulant medication
- No ethnic or racial groups will be excluded.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00100230
Start Date
September 1 2004
End Date
August 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231