H E Bartlett1, F Eperjesi. 1. Opthalmic Research Group, School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, UK. H.E.Bartlett@aston.ac.uk
Abstract
OBJECTIVE: The aim of the study is to determine the effect of lutein combined with vitamin and mineral supplementation on contrast sensitivity in people with age-related macular disease (ARMD). DESIGN: A prospective, 9-month, double-masked randomized controlled trial. SETTING: Aston University, Birmingham, UK and a UK optometric clinical practice. SUBJECTS:Age-related maculopathy (ARM) and atrophic age-related macular degeneration (AMD) participants were randomized (using a random number generator) to either placebo (n=10) or active (n=15) groups. Three of the placebo group and two of the active group dropped out. INTERVENTIONS: The active group supplemented daily with 6 mg lutein combined with vitamins and minerals. The outcome measure was contrast sensitivity (CS) measured using the Pelli-Robson chart, for which the study had 80% power at the 5% significance level to detect a change of 0.3 log units. RESULTS: The CS score increased by 0.07+/-0.07 and decreased by 0.02+/-0.18 log units for the placebo and active groups, respectively. The difference between these values is not statistically significant (z=-0.903, P=0.376). CONCLUSION: The results suggest that 6 mg of lutein supplementation in combination with other antioxidants is not beneficial for this group. Further work is required to establish optimum dosage levels.
RCT Entities:
OBJECTIVE: The aim of the study is to determine the effect of lutein combined with vitamin and mineral supplementation on contrast sensitivity in people with age-related macular disease (ARMD). DESIGN: A prospective, 9-month, double-masked randomized controlled trial. SETTING: Aston University, Birmingham, UK and a UK optometric clinical practice. SUBJECTS: Age-related maculopathy (ARM) and atrophic age-related macular degeneration (AMD) participants were randomized (using a random number generator) to either placebo (n=10) or active (n=15) groups. Three of the placebo group and two of the active group dropped out. INTERVENTIONS: The active group supplemented daily with 6 mg lutein combined with vitamins and minerals. The outcome measure was contrast sensitivity (CS) measured using the Pelli-Robson chart, for which the study had 80% power at the 5% significance level to detect a change of 0.3 log units. RESULTS: The CS score increased by 0.07+/-0.07 and decreased by 0.02+/-0.18 log units for the placebo and active groups, respectively. The difference between these values is not statistically significant (z=-0.903, P=0.376). CONCLUSION: The results suggest that 6 mg of lutein supplementation in combination with other antioxidants is not beneficial for this group. Further work is required to establish optimum dosage levels.
Authors: Martha P Montgomery; Freya Kamel; Margaret A Pericak-Vance; Jonathan L Haines; Eric A Postel; Anita Agarwal; Marie Richards; William K Scott; Silke Schmidt Journal: Ophthalmic Epidemiol Date: 2010 Jan-Feb Impact factor: 1.648