European health care systems, as elsewhere, are striving to meet the challenge of caring for a growing number of seniors. By 2050, the number of people over 65 in the EU will increase by 70 percent, and the number of people over age 80 will grow by 170 percent. Therapeutic interventions that are effective, affordable and well-tolerated in the prevention of chronic disease could have an outstanding impact on public health as a whole and are urgently needed.
Among the most promising interventions that meet these requirements are vitamin D supplementation, marine omega-3 fatty acids supplementation, and physical exercise. However, their individual and combined effects have yet to be confirmed in a clinical trial until now.
DO-HEALTH is Europe’s largest clinical trial in support of health at an older age, and the name is derived from the interventions under study: the Vitamin D3-Omega3-Home Exercise - HeALTHy Ageing and Longevity Trial. A large, three-year, multi-centre clinical trial, the DO-HEALTH study will generate needed efficacy and safety data for these interventions in the prevention of age-related diseases in seniors.
The DO-HEALTH trial will enroll 2,152 community-dwelling men and women aged 70 and older, who will be randomized into a 2x2x2 factorial design involving three interventions. The primary endpoints are bone health, muscle strength, cardiovascular health, brain function, and immune system health. Researchers will also be looking at secondary endpoints, including risk of hip fracture and rate of falls.
In addition, the study is collecting biospecimens for analysis of future biomarkers. The study leadership is critically aware of the importance of sample integrity, controlling pre-analytical variables, and storage and handling of the samples according to best practices, and chose Fisher BioServices to serve as the biobanking partner for the DO-HEALTH trial.
The DO-HEALTH website (http://do-health.eu/wordpress) provides a continuous update on recruitment. Information is also available at the study’s EC website: http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do-health_en.html. Additional information about EC Framework7 can be found at http://ec.europa.eu/researcg/fp7.
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