Literature DB >> 15364708

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

Eliot L Berson1, 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.   

Abstract

OBJECTIVE: To determine whether a therapeutic dose of docosahexaenoic acid (DHA), an omega-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 omega-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 omega-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.

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Year:  2004        PMID: 15364708     DOI: 10.1001/archopht.122.9.1297

Source DB:  PubMed          Journal:  Arch Ophthalmol        ISSN: 0003-9950


  61 in total

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