DO-HEALTH / Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial
NCT ID: NCT01745263
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2157 participants
INTERVENTIONAL
2012-12-20
2018-01-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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/
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
NCT05062018
Vitamin D Supplementation and Muscle Function in Older Adults
NCT02015611
A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)
NCT00242476
Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)
NCT04341818
Vitamin D and Physical Function in Older Adults
NCT00710957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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/
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VitD-Omega3-StrengthExercise
Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week)
Vitamin D3
2000 IU/d
Omega 3 fatty acids
Ratio EPA:DHA = 1:2
1 g/d
Strength Home Exercise
VitD-Omega3-FlexibilityExercise
Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week)
Vitamin D3
2000 IU/d
Omega 3 fatty acids
Ratio EPA:DHA = 1:2
1 g/d
Flexibility Home Exercise
Placebo-Omega3-StrengthExercise
Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Strength Home Exercise (3\*30 minutes/week)
Omega 3 fatty acids
Ratio EPA:DHA = 1:2
1 g/d
Strength Home Exercise
Placebo-Omega3-FlexibilityExercise
Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3\*30 minutes/week)
Omega 3 fatty acids
Ratio EPA:DHA = 1:2
1 g/d
Flexibility Home Exercise
VitD-Placebo-StrengthExercise
Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Strength Home Exercise (3\*30 minutes/week)
Vitamin D3
2000 IU/d
Strength Home Exercise
VitD-Placebo-FlexiblityExercise
Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Flexibility Home Exercise (3\*30 minutes/week)
Vitamin D3
2000 IU/d
Flexibility Home Exercise
Placebo-Placebo-StrengthExercise
Placebo Vitamin D3; Placebo Omega-3 fatty acids; Strength Home Exercise (3\*30 minutes/week)
Strength Home Exercise
Placebo-Placebo-FlexibilityExercise
Placebo Vitamin D3; Placebo Omega-3 fatty acids; Flexibility Home Exercise (3\*30 minutes/week)
Flexibility Home Exercise
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin D3
2000 IU/d
Omega 3 fatty acids
Ratio EPA:DHA = 1:2
1 g/d
Strength Home Exercise
Flexibility Home Exercise
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mini Mental State Examination Score of at least 24
* Living in the community
* Sufficiently mobile to come to the study centre
* Able to walk 10 meters with or without a walking aid and able to get in and out of a chair without help
* Able to swallow study capsules
* Able and willing to participate, sign informed consent (including consent to analyze all samples until drop-out or withdrawal) and cooperate with study procedures
Exclusion Criteria
* Unwillingness to limit calcium supplement dose to 500 mg per day for the duration of the trial
* Taking omega-3 fat supplements in the 3 month prior to enrolment and unwilling to forgo their use for the duration of the trial
* Use of any active vitamin D metabolite (i.e. Rocaltrol, alphacalcidiol), PTH treatment (i.e. Teriparatide), or Calcitonin at baseline and unwillingness to forego these treatments during the course of the trial
* Current or recent (previous 4 months) participation in another clinical trial, or plans of such participation in the next 3 years (corresponding to DO-HEALTH length)
* Presence of the following diagnosed health conditions in the last 5 years: history of cancer (except non-melanoma skin cancer); myocardial infarction, stroke, transient ischemic attack, angina pectoris, or coronary artery intervention
* Severe renal impairment (creatinine clearance = 15 ml/min) or dialysis, hypercalcaemia (\> 2.6 mmol/l)
* Hemiplegia or other severe gait impairment
* History of hypo- or primary hyperparathyroidism
* Severe liver disease
* History of granulomatous diseases (i.e. tuberculosis, sarcoidosis)
* Major visual or hearing impairment or other serious illness that would preclude participation
* Living with a partner who is enrolled in DO-HEALTH (i.e. only one person per household can be enrolled)
* Living in assisted living situations or a nursing home
* Temporary exclusion: acute fracture in the last 6 weeks
* Epilepsy and/or use of anti-epileptic drugs
* Individuals who fell more than 3 times in the last month
* Osteodystrophia deformans (M. Paget, Paget's disease)
* For study centers in Germany only: persons who are institutionalized / in prison by court order (§40, Abs. 1, Art. 4, "Gesetz über den Verkehr mit Arzneimitteln").
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Recruitment Partners
UNKNOWN
University of Geneva, Switzerland
OTHER
University of Basel
OTHER
University Hospital, Toulouse, France (Prof. Bruno Vellas, MD)
UNKNOWN
Charite University, Berlin, Germany
OTHER
Medical University Innsbruck
OTHER
University of Coimbra, Portugal (Prof. José daSilva, MD)
UNKNOWN
Other University Partners
UNKNOWN
University of Sheffield
OTHER
University of Manchester, UK (Prof. David Felson, MD MPH)
UNKNOWN
Max Rubner University, Germany (Prof. Bernhard Watzl, PhD)
UNKNOWN
Technische Universität Dresden
OTHER
Impact Partner
UNKNOWN
International Osteoporosis Foundation (IOF; Prof. John Kanis, MD)
UNKNOWN
SME Partners
UNKNOWN
Ferrari Data Solution
OTHER
Gut Pictures, Switzerland (Benno Gut; animated exercise video)
UNKNOWN
NOVAMEN, France (Sandrine Rival; logistic management partner)
UNKNOWN
Pharmalys, UK (Marieme Ba; monitoring partner)
UNKNOWN
Industry Partners
UNKNOWN
DSM Nutritional Products (Dr. Elisabeth Stöcklin PhD, Dr. Manfred Eggersdorfer PhD)
UNKNOWN
Nestlé (Michaela Höhne PhD, Irène Corthesy PhD)
UNKNOWN
Roche Diagnostics GmbH
INDUSTRY
European Commission
OTHER
Further collaborators and advisors at website do-health.eu
UNKNOWN
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Heike Bischoff-Ferrari
Director, Centre on Aging and Mobility
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heike Bischoff Ferrari, Prof MD
Role: PRINCIPAL_INVESTIGATOR
"Centre on Aging and Mobility" University of Zurich, University Hospital Zurich and City Hospital Waid.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Innsbruck
Innsbruck, , Austria
University of Toulouse - Centre de Recherche - Gérontopôle Hôpital La Grave
Toulouse, , France
Charité Berlin
Berlin, , Germany
University of Coimbra - Clínica Universitária de Reumatologia
Coimbra, , Portugal
Centre on Aging and Mobility, University of Zurich and City Hospital Waid
Zurich, Canton of Zurich, Switzerland
Basel University
Basel, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kistler-Fischbacher M, Gohar G, de Godoi Rezende Costa Molino C, Geiling K, Meyer-Heim T, Kressig RW, Orav EJ, Vellas B, Guyonnet S, da Sliva JAP, Rizzoli R, Armbrecht G, Steinhagen-Thiessen E, Egli A, Bischoff-Ferrari HA. Cognitive function in generally healthy adults age 70 years and older in the 5-country DO-HEALTH study: MMSE and MoCA scores by sex, education and country. Aging Clin Exp Res. 2025 Mar 17;37(1):88. doi: 10.1007/s40520-025-02946-4.
de Godoi Rezende Costa Molino C, Forster CK, Wieczorek M, Orav EJ, Kressig RW, Vellas B, Egli A, Freystaetter G, Bischoff-Ferrari HA; DO-HEALTH Research Group. Association of fall risk-increasing drugs with falls in generally healthy older adults: a 3-year prospective observational study of the DO-HEALTH trial. BMC Geriatr. 2024 Nov 29;24(1):980. doi: 10.1186/s12877-024-05557-2.
Gaengler S, Sadlon A, De Godoi Rezende Costa Molino C, Willett WC, Manson JE, Vellas B, Steinhagen-Thiessen E, Von Eckardstein A, Ruschitzka F, Rizzoli R, da Silva JAP, Kressig RW, Kanis J, Orav EJ, Egli A, Bischoff-Ferrari HA. Effects of vitamin D, omega-3 and a simple strength exercise programme in cardiovascular disease prevention: The DO-HEALTH randomized controlled trial. J Nutr Health Aging. 2024 Feb;28(2):100037. doi: 10.1016/j.jnha.2024.100037. Epub 2024 Jan 9.
Gagesch M, Wieczorek M, Abderhalden LA, Lang W, Freystaetter G, Armbrecht G, Kressig RW, Vellas B, Rizzoli R, Blauth M, Orav EJ, Egli A, Bischoff-Ferrari HA. Grip strength cut-points from the Swiss DO-HEALTH population. Eur Rev Aging Phys Act. 2023 Aug 5;20(1):13. doi: 10.1186/s11556-023-00323-6.
Bischoff-Ferrari HA, Willett WC, Manson JE, Dawson-Hughes B, Manz MG, Theiler R, Braendle K, Vellas B, Rizzoli R, Kressig RW, Staehelin HB, Da Silva JAP, Armbrecht G, Egli A, Kanis JA, Orav EJ, Gaengler S. Combined Vitamin D, Omega-3 Fatty Acids, and a Simple Home Exercise Program May Reduce Cancer Risk Among Active Adults Aged 70 and Older: A Randomized Clinical Trial. Front Aging. 2022 Apr 25;3:852643. doi: 10.3389/fragi.2022.852643. eCollection 2022.
de Godoi Rezende Costa Molino C, Chocano-Bedoya PO, Sadlon A, Theiler R, Orav JE, Vellas B, Rizzoli R, Kressig RW, Kanis JA, Guyonnet S, Lang W, Egli A, Bischoff-Ferrari HA; DO-HEALTH Research Group. Prevalence of polypharmacy in community-dwelling older adults from seven centres in five European countries: a cross-sectional study of DO-HEALTH. BMJ Open. 2022 Apr 29;12(4):e051881. doi: 10.1136/bmjopen-2021-051881.
Schietzel S, Chocano-Bedoya PO, Sadlon A, Gagesch M, Willett WC, Orav EJ, Kressig RW, Vellas B, Rizzoli R, da Silva JAP, Blauth M, Kanis JA, Egli A, Bischoff-Ferrari HA. Prevalence of healthy aging among community dwelling adults age 70 and older from five European countries. BMC Geriatr. 2022 Mar 2;22(1):174. doi: 10.1186/s12877-022-02755-8.
Bischoff-Ferrari HA, Vellas B, Rizzoli R, Kressig RW, da Silva JAP, Blauth M, Felson DT, McCloskey EV, Watzl B, Hofbauer LC, Felsenberg D, Willett WC, Dawson-Hughes B, Manson JE, Siebert U, Theiler R, Staehelin HB, de Godoi Rezende Costa Molino C, Chocano-Bedoya PO, Abderhalden LA, Egli A, Kanis JA, Orav EJ; DO-HEALTH Research Group. Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial. JAMA. 2020 Nov 10;324(18):1855-1868. doi: 10.1001/jama.2020.16909.
Related Links
Access external resources that provide additional context or updates about the study.
European Commission project link for DO-HEALTH
Website DO-HEALTH Consortium
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DO-HEALTH
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KEK-ZH-2012-0249
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.