Dose Ranging Study of Lutein Supplementation in Persons Aged 60 Years or Older

Publication Type
Journal Article
Year of Publication
Rosenthal, J; Kim, J; de Monastario, F; Thompson, DJS; Bone, R; Landrum, J; Moura, F; Khachik, F; Chen, H; Schleicher, R; Ferris, F; Chew, E
Invest Ophthalmol Vis Sci
Start Page
Date Published
Administration- Oral; Aged; Chromatography- High Pressure Liquid; Dietary Supplements; Dose-Response Relationship- Drug; Female; Food Habits; Lutein; Macular Degeneration; Male; Middle Aged; visual acuity; Visual Fields; Xanthophylls; zeaxanthin
PURPOSE: To examine the dose-response relationship between oral lutein supplementation and serum lutein concentrations in persons aged 60 years and older, with or without age-related macular degeneration (AMD). METHODS: Forty-five participants with no AMD, large drusen, or advanced AMD, were randomized to receive one of three doses (2.5, 5, or 10 mg) of lutein for 6 months and to be observed for 6 additional months after the cessation of lutein supplementation. RESULTS: The mean age of the participants (33 women) was 71 years (range: 60-91). The serum lutein concentrations of each dose group were similar before supplementation, increased at 1 month, and peaked by 3 months. Median serum concentrations of the 2.5-, 5-, and 10-mg groups from baseline to month 6 increased from 18.7 to 35.1 microg/dL (2-fold increase), from 17.8 to 59.2 microg/dL (2.9-fold increase), and from 15.1 to 66.8 microg/dL (4-fold increase), respectively (all P < 0.001). The increases in lutein serum concentrations did not vary with AMD disease severity (P = 0.98). No toxicity was observed with any dose of lutein. No significant changes were detected in visual acuity or visual field tests. CONCLUSIONS: Increasing doses of lutein supplements significantly increased the serum levels of lutein and zeaxanthin, and doses up to 10 mg were safely administered. A long-term large clinical trial is necessary to investigate the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.