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Clinical Trial
. 2010 Apr;128(4):403-11.
doi: 10.1001/archophthalmol.2010.32.

Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A

Eliot L Berson  1 , Bernard Rosner, Michael A Sandberg, Carol Weigel-DiFranco, Robert J Brockhurst, K C Hayes, Elizabeth J Johnson, Ellen J Anderson, Chris A Johnson, Alexander R Gaudio, Walter C Willett, Ernst J Schaefer
Affiliations
Clinical Trial

Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A

Eliot L Berson et al. Arch Ophthalmol. 2010 Apr.

Abstract

Objective: To determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A.

Design: Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received 12 mg of lutein or a control tablet daily. All were given 15,000 IU/d of vitamin A palmitate. Randomization took into account genetic type and baseline serum lutein level.

Main outcome measures: The primary outcome was the total point score for the Humphrey Field Analyzer (HFA) 30-2 program; prespecified secondary outcomes were the total point scores for the 60-4 program and for the 30-2 and 60-4 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Retinopathy Study acuity.

Results: No significant difference in rate of decline was found between the lutein plus vitamin A and control plus vitamin A groups over a 4-year interval for the HFA 30-2 program. For the HFA 60-4 program, a decrease in mean rate of sensitivity loss was observed in the lutein plus vitamin A group (P = .05). Mean decline with the 60-4 program was slower among those with the highest serum lutein level or with the highest increase in macular pigment optical density at follow-up (P = .01 and P = .006, respectively). Those with the highest increase in macular pigment optical density also had the slowest decline in HFA 30-2 and 60-4 combined field sensitivity (P = .005). No significant toxic effects of lutein supplementation were observed.

Conclusion: Lutein supplementation of 12 mg/d slowed loss of midperipheral visual field on average among nonsmoking adults with retinitis pigmentosa taking vitamin A. Application to Clinical Practice Data are presented that support use of 12 mg/d of lutein to slow visual field loss among nonsmoking adults with retinitis pigmentosa taking vitamin A.

Trial registration: ClinicalTrials.gov Identifier: NCT00346333.

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Figures

Figure 1
Figure 1
Box plots of serum lutein at baseline and follow-up. Horizontal lines designate the median, 25th, and 75th percentiles; vertical lines define the upper quartile plus 1.5 times the inter-quartile range and the lower quartile minus 1.5 times the inter-quartile range.
Figure 2
Figure 2
Percent of cases of patients with retinitis pigmentosa by annual rate of change of HFA 30-2 sensitivity and HFA 60-4 sensitivity by treatment group for each eye.
Figure 3
Figure 3
Spline regression of the annual change in HFA 60-4 total point score by serum lutein based on 269 eyes of 163 patients with retinitis pigmentosa.
See this image and copyright information in PMC

Comment in

References

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    1. Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993;111:761–772. - PubMed
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