Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment

Eliot L. Berson, Bernard Rosner, Michael A. Sandberg, Carol Weigel-DiFranco, Ann Moser, Robert J. Brockhurst, K. C. Hayes, Chris A. Johnson, Ellen J. Anderson, Alexander R. Gaudio, Walter C. Willett, Ernst J. Schaefer

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To determine whether a therapeutic dose of docosahexaenoic acid (DHA), an ω-3 fatty acid, will slow the course of retinal degeneration in adult patients with retinitis pigmentosa who are also receiving vitamin A. Design: Randomized, controlled, double-masked trial of 221 patients, aged 18 to 55 years, evaluated over a 4-year interval. Patients were given either 1200 mg/d of docosahexaenoic acid or control capsules. All were given 15000 IU/d of vitamin A (given as retinyl palmitate). Randomization considered genetic type and baseline dietary ω-3 fatty acid intake. Main Outcome Measures: The primary outcome measure was the total point score for the 30-2 program of the Humphrey field analyzer; secondary outcome measures were the total point score for the 30-2 and 30/60-1 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Rentinopathy Study visual acuity. Results: No significant differences in decline in ocular function were found between the docosahexaenoic acid plus vitamin A (DHA + A) group and control plus vitamin A (control + A) group over a 4-year interval among all 221 randomized patients or among the 208 patients who completed all 4 follow-up visits. The mean annual rate of loss of sensitivity for the Humphrey Field Analyzer 30-2 program was 37 dB for the DHA + A group and 38 dB for the control + A group (P = .88). For the Humphrey Field Analyzer 30-2 and 30/60-1 programs combined, the mean annual rates of loss of field sensitivity were 57 dB for the DHA + A group and 60 dB (P = .73) for control + A group. No toxic adverse effects were observed. No significant differences by treatment group assignment were observed within genetic types or within the category of baseline ω-3 fatty acid intake. Conclusion: In patients assigned to receive 15000 IU/d of vitamin A, this randomized trial showed that 1200 mg/d of docosahexaenoic acid supplementation over a 4-year interval did not, on average, slow the course of disease in patients with retinitis pigmentosa.

Original languageEnglish (US)
Pages (from-to)1297-1305
Number of pages9
JournalArchives of ophthalmology
Volume122
Issue number9
DOIs
StatePublished - Sep 2004

ASJC Scopus subject areas

  • Ophthalmology

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