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	Treatment or Intervention
Retinitis Pigmentosa	Drug: docosahexaenoic acid

Further Study Details: 

Expected Total Enrollment:  46

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

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

Study chairs or principal investigators

Dennis R. Hoffman,  Study Chair,  Retina Foundation of the Southwest   

Study ID Numbers:  199/13351; RFS-FDR001232
Record last reviewed:  May 1998
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004827
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08