Retinitis Pigmentosa
Conditions
Keywords
ophthalmologic disorders, rare disease, retinitis pigmentosa
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.
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
Interventions
DRUGdocosahexaenoic acid
Sponsors
Retina Foundation of the Southwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of X-linked retinitis pigmentosa Early stage disease Sufficient cone function determined by recordable ERG (30 Hz amplitude; greater than 0.32 microvolts) Visual fields greater than 20 degrees Sufficient rod function (greater than 3.0 microvolts amplitude) Media clarity sufficient for fundus photography --Prior/Concurrent Therapy-- No concurrent use of anticoagulant medication --Patient Characteristics-- * No chronic metabolic disease that may interfere with fatty acid metabolism * No bleeding of clinical significance
Outcome results
None listed