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Phase III Trial of Cold Water Fish Oil and Antioxidants for Control/Prevention of Age-Related Macular Degeneration

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By Editor • www.ProHealth.com • October 25, 2006


The National Eye Institute is seeking to enroll 4,000 individuals ages 50 to 85 diagnosed with age-related macular degeneration (AMD) for a phase III, 100-location national study in the U.S. – “Age-Related Eye Disease Study 2 (AREDS2).”

AMD is a leading cause of vision loss in the senior population, affecting 10 percent of those ages 65 to 75, and increasing to 30 percent of those over age 80. AREDS2 is an “interventional” study that will follow participants for a minimum of five years, comparing the effect of different combinations and doses of dietary supplements that are believed to be beneficial for controlling or preventing AMD’s progression, based on a number of previous studies.

Most importantly, AREDS2 will be a randomized, double blinded, dose-comparison study to evaluate the effect on development of advanced AMD of:

n High supplemental doses of the dietary omega-3 long-chain polyunsaturated fatty acids DHA and EPA (both most commonly found in fish oil).

n And/or high supplemental doses of dietary xanthophylls (the carotinoid antioxidants lutein and zeaxanthin, which are found in the retina).

The study will also build on results from the earlier "Age-Related Eye Disease Study (AREDS)" released five years ago. The initial study found that “high-dose antioxidant vitamins and minerals (vitamins C and E, beta-carotene, zinc, and copper), taken by mouth, reduced the risk of progression to advanced AMD by 25 percent, and the risk of moderate vision loss by 19 percent.”

Accordingly, participants of AREDS2 will be offered additional treatment with the original AREDS formulation (now considered standard of care) and three variations of this formula. These are: 1) no beta-carotene; 2) lower amounts of zinc; and 3) no beta-carotene and lower amounts of zinc.

Broad details of the trial’s purpose, background, patient eligibility criteria, contact information, and links to a list of nearly 100 trial sites are provided by ClinicalTrials.gov at http://www.clinicaltrials.gov/ct/show/NCT00345176. In enquiring about the study, refer to its ClinicalTrials.gov reference identifier - NCT00345176.




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