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

Retina Foundation of the Southwest46 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

docosahexaenoic acidDRUG

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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