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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Retina Foundation of the Southwest |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004827 |
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.
Condition | Intervention |
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Retinitis Pigmentosa |
Drug: docosahexaenoic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment |
Estimated Enrollment: | 46 |
Study Start Date: | March 1996 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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--
Study ID Numbers: | 199/13351, RFS-FDR001232 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004827 History of Changes |
Health Authority: | United States: Federal Government |
ophthalmologic disorders rare disease retinitis pigmentosa |
Pigmentary Retinopathy Cone Rod Dystrophy Genetic Diseases, Inborn Eye Diseases Retinitis Pigmentosa |
Rare Diseases Retinitis Retinal Degeneration Eye Diseases, Hereditary Retinal Diseases |
Genetic Diseases, Inborn Eye Diseases Retinitis Pigmentosa Retinitis |
Retinal Degeneration Eye Diseases, Hereditary Retinal Diseases |