Improve Healthy Ageing in Seniors; Prevent Disease at Older Age Clinical Trial
Official title:
Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial (Acronym: DO-HEALTH)
The European population is aging rapidly which poses a challenge on the individual, the
European societies, and health care systems. Among the most promising public health
interventions that may extend healthy life expectancy at older age are vitamin D, marine
omega-3 fatty acids and physical exercise. However, their individual and combined effects
have yet to be confirmed in a clinical trial.
The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The
specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home
exercise program will prevent disease at older age.
To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70
years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors
will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck
and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home
exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This
will allow to test the individual and the combined benefit of the interventions in the
prevention of 5 primary endpoints: incident non-vertebral fractures; functional decline;
systolic and diastolic blood pressure change; cognitive decline; and the rate of any
infection. Key secondary endpoints include incidence of hip fractures, rate of falls,
severity of pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and
oral health, quality of life, and mortality.
All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the
effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will
further evaluate reasons why or why not seniors adhere to the 3 interventions, and will
assess their cost-benefit in a health economic model based on documented health care
utilization and observed incidence of chronic disease.
website DO-HEALTH: http://do-health.eu/wordpress/
The 3 primary treatment comparisons are:
1. 2000 IU vitamin D per day compared to placebo (controlling for the other treatment
strategies)
2. 1 g of omega-3 fatty acids (EPA+DHA, ratio 1:2, from marine algae) compared to placebo
(controlling for the other treatment strategies)
3. Home exercise program (muscle strength) of 30 minutes 3 times a week compared to a
control exercise program (joint flexibility) 30 minutes 3 times a week
Follow-up: DO-HEALTH seniors will be followed for 3 years, in-person, and in 3-monthly
intervals (4 clinical visits and 9 phone calls) at the 7 recruitment centers.
Study population: DO-HEALTH will enroll seniors age 70 years and older. To represent the
largest part of the senior population, DO-HEALTH will recruit community-dwelling seniors.
However, to represent also the pre-frail population at risk of institutionalization, at least
40% of seniors will be enrolled based on a fall with or without a fracture in the year before
DO-HEALTH enrolment.
Study Design: This is a randomized, double-blind, placebo-controlled, 2×2×2 factorial design
clinical trial.
Recruitment Centers: The trial will be performed at 7 recruitment centers located in 5
countries: Switzerland (University of Zurich, Basel University Hospital, Geneva University
Hospital), France (University of Toulouse Hospital Centre), Germany (Charité Berlin),
Portugal (University of Coimbra), and Austria (Innsbruck Medical University).
Randomization: Stratified block randomization. Labeling of study intervention will be
performed by a central randomization centre in Switzerland.
Stratification variables: recruitment centre (7 centers), fall during previous 12 months
(yes/no), gender, and age (70 - 84 and 85+). At least 40% of Seniors among those who fell or
did not fall during the last year will be enforced at each of the 7 recruitment centers.
Gender and age distribution will be monitored within each recruitment centre with the
DO-HEALTH randomization software. If gross imbalance (less than 30% of fallers/non-fallers in
a stratum) is detected within a centre, recruitment strategies for the centre will be adapted
to boost recruitment of participants of underrepresented category.
website DO-HEALTH: http://do-health.eu/wordpress/
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