• Arch Ophthalmol Chic · Jun 1993

    Randomized Controlled Trial Comparative Study Clinical Trial

    A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa.

    • E L Berson, B Rosner, M A Sandberg, K C Hayes, B W Nicholson, C Weigel-DiFranco, and W Willett.
    • Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston 02114.
    • Arch Ophthalmol Chic. 1993 Jun 1; 111 (6): 761-72.

    ObjectiveTo determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa.DesignRandomized, controlled, double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years. Electroretinograms, visual field area, and visual acuity were measured annually.SettingClinical research facility.Patients601 patients aged 18 through 49 years with retinitis pigmentosa meeting preset eligibility criteria. Ninety-five percent of the patients completed the study. There were no adverse reactions.InterventionPatients were assigned to one of four treatment groups receiving 15,000 IU/d of vitamin A, 15,000 IU/d of vitamin A plus 400 IU/d of vitamin E, trace amounts of both vitamins, or 400 IU/d of vitamin E.Main Outcome MeasureCone electroretinogram amplitude.ResultsThe two groups receiving 15,000 IU/d of vitamin A had on average a slower rate of decline of retinal function than the two groups not receiving this dosage (P = .01). Among 354 patients with higher initial amplitudes, the two groups receiving 15,000 IU/d of vitamin A were 32% less likely to have a decline in amplitude of 50% or more from baseline in a given year than those not receiving this dosage (P = .01), while the two groups receiving 400 IU/d of vitamin E were 42% more likely to have a decline in amplitude of 50% or more from baseline than those not receiving this dosage (P = .03). While not statistically significant, similar trends were observed for rates of decline of visual field area. Visual acuity declined about 1 letter per year in all groups.ConclusionsThese results support a beneficial effect of 15,000 IU/d of vitamin A and suggest an adverse effect of 400 IU/d of vitamin E on the course of retinitis pigmentosa.

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