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

¹From the Clinical Trials Branch, Division of Epidemiology and Clinical Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland; the ²EMMES Corporation, Rockville, Maryland; the ³Office of the Clinical Director, National Eye Institute, National Institutes of Health, Bethesda, Maryland; the ⁴Department of Chemistry and Biochemistry, Florida International University, Miami, FL; the ⁵Joint Institute for Food Safety and Applied Nutrition, Department of Chemistry and Biochemistry, University of Maryland, College Park, Maryland; and the ⁶Centers for Disease Control and Prevention, Atlanta, Georgia.

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 µg/dL (2-fold increase), from 17.8 to 59.2 µg/dL (2.9-fold increase), and from 15.1 to 66.8 µg/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.

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