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

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 vitaminAand control plus vitamin A groups over a 4-year interval for the HFA 30-2 program. For the HFA60-4 program, a decrease in mean rate of sensitivity loss was observed in the lutein plus vitaminAgroup (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 andP=.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).Nosignificant 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. ©2010 American Medical Association. All rights reserved.