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Study of Docosahexaenoic Acid (DHA) Supplementation in Patients with X-Linked Retinitis Pigmentosa



Study of Docosahexaenoic Acid (DHA) Supplementation in Patients with X-Linked Retinitis Pigmentosa

For Condition: Retinitis Pigmentosa
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Retina Foundation of the Southwest
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Parallel Assignment
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry 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
Total Enrollment: 46

Location and Contact Information:

Overall Study Official:
DennisHoffman,  Study Chair,  Retina Foundation of the Southwest


Additional Information:
Study ID Numbers:  199/13351;  RFS-FDR001232
Study Start Date: March 1996
Record last reviewed: May 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004827

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4. A Genetic Analysis of Usher Syndrome in Ashkenazi Jews

5. Study of Dietary N-3 Fatty Acids in Patients with Retinitis Pigmentosa and Usher Syndrome

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