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DO-HEALTH : Vitamin D3 - Omega3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors
Bischoff-Ferrari, Heike A. de Godoi Rezende Costa Molino, Caroline Rival, Sandrine Vellas, Bruno Rizzoli, René Kressig, Reto W. Kanis, John A. Manson, JoAnn E. Dawson-Hughes, Bess Orav, Endel J.
Bischoff-Ferrari, Heike A.
de Godoi Rezende Costa Molino, Caroline
Rival, Sandrine
Vellas, Bruno
Rizzoli, René
Kressig, Reto W.
Kanis, John A.
Manson, JoAnn E.
Dawson-Hughes, Bess
Orav, Endel J.
Author
Bischoff-Ferrari, Heike A.
de Godoi Rezende Costa Molino, Caroline
Rival, Sandrine
Vellas, Bruno
Rizzoli, René
Kressig, Reto W.
Kanis, John A.
Manson, JoAnn E.
Dawson-Hughes, Bess
Orav, Endel J.
da Silva, José A. P.
Blauth, Michael
Felsenberg, Dieter
Ferrari, Stephen M.
Theiler, Robert
Egli, Andreas
de Godoi Rezende Costa Molino, Caroline
Rival, Sandrine
Vellas, Bruno
Rizzoli, René
Kressig, Reto W.
Kanis, John A.
Manson, JoAnn E.
Dawson-Hughes, Bess
Orav, Endel J.
da Silva, José A. P.
Blauth, Michael
Felsenberg, Dieter
Ferrari, Stephen M.
Theiler, Robert
Egli, Andreas
Abstract
DO-HEALTH is a multi-center clinical trial among 2157 community-dwelling European men and women age 70 and older. The 2x2x2 randomized-control factorial design trial tested the individual and additive benefit, as well as the cost-effectiveness, of 3 interventions: vitamin D 2000 IU/day, omega-3 fatty acids 1000 mg/day (EPA + DHA, ratio 1:2), and a 30-minute 3 times/week home exercise (strength versus flexibility). Each treatment tested has shown considerable prior promise from mechanistic studies, small clinical trials, or large cohort studies, in the prevention of common age-related chronic diseases, but definitive data are missing. DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty). As the 3 interventions have distinct mechanisms of action for each of the 6 primary endpoints, a maximum benefit is expected for their additive benefit as a “multi-modal” intervention. The trial duration is 3 years with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls. Baseline and follow-up blood samples were collected in all participants to measure changes in 25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations. Our objective was to test interventions that are expected to promote healthy aging and longer life expectancy and that can be easily and safely implemented by older community-dwelling adults.
Keywords
omega-3, vitamin d, home exercise, community-dwelling older adults, randomized clinical trial, preventive health
Date
2021
Type
Journal article
Journal
Contemporary Clinical Trials
Book
Volume
100
Issue
Page Range
1-13
Article Number
Article 106124
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY-NC-ND 4.0
File Access
Open