Central Retinal Enrichment Supplementation Trials (CREST): design and methodology of the CREST randomized controlled trials.

Akuffo, Kwadwo Owusu and Beatty, Stephen and Stack, Jim and Dennison, Jessica and O'Regan, Sarah and Meagher, Katherine A and Peto, Tunde and Nolan, John (2014) Central Retinal Enrichment Supplementation Trials (CREST): design and methodology of the CREST randomized controlled trials. Ophthalmic epidemiology, 21 (2). pp. 111-23. ISSN 1744-5086

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Official URL: http://informahealthcare.com/doi/abs/10.3109/09286...

Abstract

PURPOSE:The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potential impact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10 mg lutein (L), 2 mg zeaxanthin (Z) and 10 mg meso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1) and in subjects with early age-related macular degeneration (AMD; Trial 2). METHODS:CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ and 2 mg Z (n = 60) or placebo (n = 60). Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ, 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention A; n = 75) or 10 mg L and 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention B; n = 75). Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondary outcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostress recovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjective visual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded. CONCLUSIONS:CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large, double-blind, randomized clinical trial.

Item Type: Article
Departments or Groups: Macular Pigment Research Group
Divisions: School of Science > Department of Chemical and Life Sciences
Depositing User: Kwadwo Akuffo
Date Deposited: 24 Sep 2014 18:49
Last Modified: 22 Aug 2016 10:27
URI: http://repository.wit.ie/id/eprint/2847

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