Submitted to: Archives of Ophthalmology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/19/2010
Publication Date: 4/20/2010
Citation: Berson, E.L., Rosner, B., Sandberg, M.A., Weigel-Difranco, C., Brockhurst, R.J., Hayes, K.C., Johnson, E.J., Anderson, E.J., Johnson, C.A., Gaudio, A.R., Willett, W.C., Schaefer, E.J. 2010. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A treatment. Archives of Ophthalmology. 128(4):403-411. Interpretive Summary: Lutein is a vitamin which is known to provide pigment to the eye. Retinitis pigmentosa is a rare disease in which patients lose their eye pigment and can go blind. In this study 225 patients with retinitis pigmentosa, all receiving vitamin A at a dose of 15,000 units/day, were given either 12 mg. of lutein/day or placebo for a 4 year period. During this time those that received the lutein had a slower loss of visual function than those that did not, indicating the lutein supplementation in these patients with retintis pigmentosa in beneficial on top of vitamin A supplementation.
Technical Abstract: We sought 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.