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- Title
A Randomized Study of Nutritional Supplementation in Patients with Unilateral Wet Age-Related Macular Degeneration.
- Authors
García-Layana, Alfredo; Recalde, Sergio; Hernandez, Maria; Abraldes, Maximino J.; Nascimento, João; Hernández-Galilea, Emiliano; Olmedilla-Alonso, Begoña; Escobar-Barranco, Jose Juan; Zapata, Miguel Angel; Silva, Rufino; Caballero Arredondo, Mariana; Lopez-Sabater, María Carmen; Mendez-Martínez, Silvia; Pardiñas-Barón, Nieves; Calvo, Pilar; Fernández-Robredo, Patricia; Chamcheu, Jean Christopher
- Abstract
The purpose of this study is evaluate the efficacy and safety of medicinal products containing the original Age-Related Eye Disease group (AREDS) formulation at doses approved in Europe (EU, control group; n = 59) with a product that adds DHA, lutein, zeaxanthin, resveratrol and hydroxytyrosol to the formula (intervention group; n = 50). This was a multicenter, randomized, observer-blinded trial conducted in patients aged 50 years or older diagnosed with unilateral exudative Age related Macular Degeneration AMD. At month 12, the intervention did not have a significant differential effect on visual acuity compared with the control group, with an estimated treatment difference in Early Treatment Diabetic Retinopathy Study (ETDRS) of −1.63 (95% CI −0.83 to 4.09; p = 0.192). The intervention exhibited a significant and, in most cases, relevant effect in terms of a reduction in some inflammatory cytokines and a greater improvement in the fatty acid profile and serum lutein and zeaxantin concentration. In patients with unilateral wet AMD, the addition of lutein, zeaxanthin, resveratrol, hydroxytyrosol and DHA to the AREDS EU recommended doses in the short-term did not have a differential effect on visual acuity compared to a standard AREDS EU formula but, in addition to improving the fatty acid profile and increasing carotenoid serum levels, may provide a beneficial effect in improving the proinflammatory and proangiogenic profile of patients with AMD.
- Subjects
EUROPE; DRUG approval; DOCOSAHEXAENOIC acid; DRUG efficacy; RESEARCH; CYTOKINES; RETINAL degeneration; CONFIDENCE intervals; NUTRITION; AGE distribution; LUTEIN; MEDICAL cooperation; DIETARY supplements; ZEAXANTHIN; RESVERATROL; RANDOMIZED controlled trials; PRE-tests &; post-tests; COMPARATIVE studies; CAROTENOIDS; DESCRIPTIVE statistics; PHARMACEUTICAL chemistry; STATISTICAL sampling; DIABETIC retinopathy; EYE diseases; FATTY acids; EVALUATION
- Publication
Nutrients, 2021, Vol 13, Issue 4, p1253
- ISSN
2072-6643
- Publication type
Article
- DOI
10.3390/nu13041253