DO-HEALTH / Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial

Summary

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/

Conditions

• Improve Healthy Ageing in Seniors; Prevent Disease at Older Age

Interventions

DRUG

Vitamin D3

2000 IU/d

DRUG

Omega 3 fatty acids

Ratio EPA:DHA = 1:2 1 g/d

PROCEDURE

Strength Home Exercise

PROCEDURE

Flexibility Home Exercise

Sponsors & Collaborators

• Recruitment Partners

  collaborator UNKNOWN

• University of Geneva, Switzerland

  collaborator OTHER

• University of Basel

  collaborator OTHER

• University Hospital, Toulouse, France (Prof. Bruno Vellas, MD)

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• University of Coimbra, Portugal (Prof. José daSilva, MD)

  collaborator UNKNOWN

• Other University Partners

  collaborator UNKNOWN

• University of Sheffield

  collaborator OTHER

• University of Manchester, UK (Prof. David Felson, MD MPH)

  collaborator UNKNOWN

• Max Rubner University, Germany (Prof. Bernhard Watzl, PhD)

  collaborator UNKNOWN

• Technische Universität Dresden

  collaborator OTHER

• Impact Partner

  collaborator UNKNOWN

• International Osteoporosis Foundation (IOF; Prof. John Kanis, MD)

  collaborator UNKNOWN

• SME Partners

  collaborator UNKNOWN

• Ferrari Data Solution

  collaborator OTHER

• Gut Pictures, Switzerland (Benno Gut; animated exercise video)

  collaborator UNKNOWN

• NOVAMEN, France (Sandrine Rival; logistic management partner)

  collaborator UNKNOWN

• Pharmalys, UK (Marieme Ba; monitoring partner)

  collaborator UNKNOWN

• Industry Partners

  collaborator UNKNOWN

• DSM Nutritional Products (Dr. Elisabeth Stöcklin PhD, Dr. Manfred Eggersdorfer PhD)

  collaborator UNKNOWN

• Nestlé (Michaela Höhne PhD, Irène Corthesy PhD)

  collaborator UNKNOWN

• Roche Diagnostics GmbH

  collaborator INDUSTRY

• European Commission

  collaborator OTHER

• Further collaborators and advisors at website do-health.eu

  collaborator UNKNOWN

• University of Zurich

  lead OTHER

Principal Investigators

• Heike Bischoff Ferrari, Prof MD · "Centre on Aging and Mobility" University of Zurich, University Hospital Zurich and City Hospital Waid.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-20

Primary Completion

2017-11-17

Completion

2018-01-19

Countries

• Austria
• France
• Germany
• Portugal
• Switzerland

Study Locations