TY - JOUR
T1 - Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment
AU - Berson, Eliot L.
AU - Rosner, Bernard
AU - Sandberg, Michael A.
AU - Weigel-DiFranco, Carol
AU - Moser, Ann
AU - Brockhurst, Robert J.
AU - Hayes, K. C.
AU - Johnson, Chris A.
AU - Anderson, Ellen J.
AU - Gaudio, Alexander R.
AU - Willett, Walter C.
AU - Schaefer, Ernst J.
N1 - Copyright:
Copyright 2009 Elsevier B.V., All rights reserved.
PY - 2004/9
Y1 - 2004/9
N2 - 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.
AB - 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.
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U2 - 10.1001/archopht.122.9.1297
DO - 10.1001/archopht.122.9.1297
M3 - Article
C2 - 15364708
AN - SCOPUS:4444344714
SN - 2168-6165
VL - 122
SP - 1297
EP - 1305
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
IS - 9
ER -