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

Arch Ophthalmol. 2004;122:1297-1305.

Objective  To determine whether a therapeutic dose of docosahexaenoic acid (DHA), an -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 15 000 IU/d of vitamin A (given as retinyl palmitate). Randomization considered genetic type and baseline dietary -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 -3 fatty acid intake.

Conclusion  In patients assigned to receive 15 000 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.

From the Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston (Drs Berson, Rosner, Sandberg, Brockhurst, and Gaudio and Mss Weigel-DiFranco and Anderson); Kennedy Krieger Institute, Peroxisomal Diseases Laboratory, Baltimore, Md (Ms Moser); Foster Biomedical Research Laboratory, Brandeis University, Waltham, Mass (Dr Hayes); Devers Eye Institute, Portland, Ore (Dr Johnson); the Department of Nutrition, Harvard School of Public Health, Boston (Dr Willett); and the Lipid Metabolism Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research, Center on Aging at Tufts University, Boston (Dr Schaefer). The authors have no relevant financial interest in this article.

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Further Evaluation of Docosahexaenoic Acid in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment: Subgroup Analyses
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