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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Zurich
Sponsor:
Collaborators:
Recruitment Partners
University of Zurich, Switzerland (Prof. Heike A. Bischoff-Ferrari, MD DrPH)
University of Geneva, Switzerland (Prof. René Rizzoli, MD)
University of Basel, Switzerland (Prof. Reto W. Kressig, MD and PD Norbert Suhm, MD)
University Hospital, Toulouse, France (Prof. Bruno Vellas, MD)
Charite University, Berlin, Germany
Medical University Innsbruck
University of Coimbra, Portugal (Prof. José daSilva, MD)
Other University Partners
University of Sheffield
University of Manchester, UK (Prof. David Felson, MD MPH)
Max Rubner University, Germany (Prof. Bernhard Watzl, PhD)
Technische Universität Dresden
Centre on Aging and Mobility, University of Zurich (Prof. Andreas Maetzel, MD PhD)
Impact Partner
International Osteoporosis Foundation (IOF; Prof. John Kanis, MD)
SME Partners
Ferrari Data Solutions GmBH, Switzerland (Stephen M. Ferrari; direct data entry platform)
Gut Pictures, Switzerland (Benno Gut; animated exercise video)
NOVAMEN, France (Sandrine Rival; logistic management partner)
Pharmalys, UK (Marieme Ba; monitoring partner)
Industry Partners
DSM Nutritional Products (Dr. Elisabeth Stöcklin PhD, Dr. Manfred Eggersdorfer PhD)
Nestlé (Michaela Höhne PhD, Irène Corthesy PhD)
Roche-Diagnostics (Monika Reuschling)
Funding within Framework 7 research program of the European Commission (project 278588)
Further collaborators and advisors at website do-health.eu
Information provided by (Responsible Party):
Heike Bischoff-Ferrari, University of Zurich
ClinicalTrials.gov Identifier:
NCT01745263
First received: December 6, 2012
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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: the risk of incident non-vertebral fractures; the risk of functional decline; the risk of blood pressure increase; the risk of cognitive decline; and the rate of any infection. Key secondary endpoints include risk of hip fracture, rate of falls, pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral health, quality of life, and life-expectancy.

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/ website EC: http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do-health_en.html


Condition Intervention Phase
Improve Healthy Ageing in Seniors; Prevent Disease at Older Age
Drug: Vitamin D3
Drug: Omega 3 fatty acids
Procedure: Strength Home Exercise
Procedure: Flexibility Home Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial (Acronym: DO-HEALTH)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Bone: Incident non-vertebral fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Confirmed by medical and/or x-ray reports

  • Muscle: Functional decline (lower extremity function) [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Measured with the SPPB (short physical performance test battery)

  • Cardio-vascular: Systolic and diastolic blood pressure change [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Standardized blood pressure assessment in sitting position

  • Brain: Cognitive decline [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Montreal Cognitive Assessment (MoCA)

  • Immunity: Rate of infections [ Time Frame: Baseline, and every 3 months up to 36 months ] [ Designated as safety issue: No ]
    3-monthly incident infection protocol


Secondary Outcome Measures:
  • Bone: Incident hip fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Based on medical records and/or x-ray reports

  • Bone: Incident total fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Combined non-vertebral and vertebral fractures among subgroup of 1502 participants with DXA vertebral morphometry assessment

  • Bone: Incident vertebral fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Based on DXA vertebral morphometry among subset of 1502 participants with DXA measurements

  • Bone: Bone mineral density decrease at the lumbar spine and hip [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    Assessed in a subset of 1502 participants with DXA measurements

  • Muscle: Rate of falls [ Time Frame: Assessed every 3 months over 36 months ] [ Designated as safety issue: No ]
    Any low trauma fall, injurious fall, faller

  • Muscle: reaction time and grip strength [ Time Frame: Baseline, 12,24,36 months ] [ Designated as safety issue: No ]
    Reaction time will be assessed with the repeated sit-to-stand test; grip strength will be assessed with the Martin Vigorimeter

  • Muscle: Muscle mass decrease at upper and lower extremities [ Time Frame: Baseline, 12,24,36 months ] [ Designated as safety issue: No ]
    Subset of 1502 participants with DXA measurements

  • Muscle: Dual tasking 10-meter gait speed [ Time Frame: Baseline, 12,24 and 36 months ] [ Designated as safety issue: No ]
  • Muscle/Bone: musculoskeletal pain [ Time Frame: Baseline, 12,24, and 36 months ] [ Designated as safety issue: No ]
    Assessed with the McGill questionnaire

  • Cardio-vascular: Incident Hypertension [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Brain: mental health decline [ Time Frame: Baseline, 12,24, and 36 months ] [ Designated as safety issue: No ]
    Assessed with Geriatric Depression Scale

  • Brain: Incident Depression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Brain/Muscle: Dual tasking gait variability [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Subset of 250 participants

  • Immunity: Rate of upper respiratory infections / rate of flu-like illness [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Assessed with infection protocol every 3 months

  • Immunity: Incident severe infections that lead to hospital admission [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Cartilage/Bone: Severity of knee pain in participants with symptomatic knee osteoarthritis [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Assessed with the KOOS questionnaire. Knee OA assessment with modified ACR criteria.

  • Cartilage/Bone: Rate of knee buckling [ Time Frame: Baseline, 12,24,36 months ] [ Designated as safety issue: No ]
    Questionnaire-based.

  • Cartilage/Bone: NSAID use / number of joints with pain [ Time Frame: Baseline, 12, 24, 36 months ] [ Designated as safety issue: No ]
    Assessed by questionnaire and homunculus figure

  • Dental: Decline in oral health [ Time Frame: Baseline, 12,24 and 36 months ] [ Designated as safety issue: No ]
    Assessed with questionnaire.

  • Dental: Tooth loss [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Assessed by tooth count at every clinical visit

  • Gastro-Intestinal: rate of GI symptoms [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Assessed with ROME III questionnaire.

  • Glucose-Metabolic: Change in fasting glucose, insulin levels (QUICKI, HOMA index) [ Time Frame: Baseline, 12,24,36 months ] [ Designated as safety issue: No ]
    Laboratory measures at the Central DO-HEALTH Laboratory (Institute of Clinical Chemistry at the University Hospital Zurich)

  • Glucose-Metabolic: Body composition [ Time Frame: Baseline, 12, 24, 36 months ] [ Designated as safety issue: No ]
    Subset of 1502 participants with DXA measurements

  • Kidney: Decline in kidney function [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    Blood creatinine levels and estimated glomerular filtration rate

  • Global Health: Quality of life [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Assessed with questionnaire (EuroQuol).

  • Global Health: Incident disability regarding activities of daily living [ Time Frame: Baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Assessed with HAQ-PROMIS questionnaire

  • Global Health: Incident nursing home admission [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Global Health: Mortality [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Large organ-specific biomarker study [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    See http://do-health.eu/wordpress/

  • Bone: Incident repeat fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Any repeat non-vertebral fractures in all participants, vertebral fractures and total fractures among subset of 1502 seniors with yearly DXA measurements

  • BONE: Functional recovery after fracture [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Muscle: Incident sarcopenia / incident frailty / decline in physical function [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Incident sarcopenia (among subset of 1502 seniors with yearly DXA measurements), incident frailty (questionnaire), decline in physical activity (questionnaire)

  • Cardio-vascular: Major cardio-vascular events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Major cardiovascular events as a composite endpoint (any event: myocardial infarction, stroke, revascularization procedures of CABG and PCI, incident congestive heart disease, cardiovascular mortality); individual endpoints: myocardial infarction, stroke, incident congestive heart disease, and cardiovascular mortality (assessed every 3 months over 36 months)

  • Brain: incident dementia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Immunity: Incident cancer / rate of implant infections / rate of gastro-intestinal infections [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Incident cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men); rate of implant infections after total hip or knee replacement (due to fracture or osteoarthritis); rate of gastro-intestinal infections

  • Cartilage/bone: Incident osteoarthritis [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    Incident symptomatic knee osteoarthritis; incident symptomatic hip osteoarthritis, incident symptomatic hand osteoarthritis; composite endpoint: incident symptomatic knee, hip or hand osteoarthritis; severity of hip pain in those with prevalent symptomatic hip osteoarthritis, severity of hand pain in those with prevalent symptomatic hand osteoarthritis

  • Adherence laboratory [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    Serum 25(OH)D concentrations (measured both by an automated assay and HPLCMS/MS) and plasma PUFA concentrations (EPA, AA, DPA, DHA; measured by a sensitive and selective assay based on gas chromatography coupled to mass spectrometry detection (GC-MS)) in all participants


Estimated Enrollment: 2152
Study Start Date: December 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VitD-Omega3-StrengthExercise
Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Strength Home Exercise (3*30 minutes/week)
Drug: Vitamin D3
2000 IU/d
Other Name: Cholecalciferol
Drug: Omega 3 fatty acids

Ratio EPA:DHA = 1:2

1 g/d

Other Name: Eicosapentaenoic acid AND Docosahexaenoic acid
Procedure: Strength Home Exercise
Active Comparator: VitD-Omega3-FlexibilityExercise
Vitamin D3 (2000 IU/d); Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3*30 minutes/week)
Drug: Vitamin D3
2000 IU/d
Other Name: Cholecalciferol
Drug: Omega 3 fatty acids

Ratio EPA:DHA = 1:2

1 g/d

Other Name: Eicosapentaenoic acid AND Docosahexaenoic acid
Procedure: Flexibility Home Exercise
Active Comparator: Placebo-Omega3-StrengthExercise
Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Strength Home Exercise (3*30 minutes/week)
Drug: Omega 3 fatty acids

Ratio EPA:DHA = 1:2

1 g/d

Other Name: Eicosapentaenoic acid AND Docosahexaenoic acid
Procedure: Strength Home Exercise
Active Comparator: Placebo-Omega3-FlexibilityExercise
Placebo Vitamin D3; Omega-3 fatty acids (1 g/d); Flexibility Home Exercise (3*30 minutes/week)
Drug: Omega 3 fatty acids

Ratio EPA:DHA = 1:2

1 g/d

Other Name: Eicosapentaenoic acid AND Docosahexaenoic acid
Procedure: Flexibility Home Exercise
Active Comparator: VitD-Placebo-StrengthExercise
Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Strength Home Exercise (3*30 minutes/week)
Drug: Vitamin D3
2000 IU/d
Other Name: Cholecalciferol
Procedure: Strength Home Exercise
Active Comparator: VitD-Placebo-FlexiblityExercise
Vitamin D3 (2000 IU/d); Placebo Omega-3 fatty acids; Flexibility Home Exercise (3*30 minutes/week)
Drug: Vitamin D3
2000 IU/d
Other Name: Cholecalciferol
Procedure: Flexibility Home Exercise
Active Comparator: Placebo-Placebo-StrengthExercise
Placebo Vitamin D3; Placebo Omega-3 fatty acids; Strength Home Exercise (3*30 minutes/week)
Procedure: Strength Home Exercise
Sham Comparator: Placebo-Placebo-FlexibilityExercise
Placebo Vitamin D3; Placebo Omega-3 fatty acids; Flexibility Home Exercise (3*30 minutes/week)
Procedure: Flexibility Home Exercise

Detailed Description:

The 3 primary treatment comparisons are:

  1. 2000 IU vitamin D per day compared to placebo (controlling for the other treatment strategies)
  2. 1 gram 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, 50% 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+). Even balance 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 participants 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/ website EC: http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do-health_en.html

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age 70 years or older
  • 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:

  • Consumption of more than 1000 IU vitamin D/day in the 36 months prior to enrollment, or a bolus of 300'000 IU or more in the last 12 month prior to enrollment, and/ or unwillingness to limit vitamin D intake to the current standard of 800 IU/day of vitamin D during the course of the trial. Provision 1: an individual who consumed an average vitamin D dose between 1000 and 2000 IU vitamin D/day in the 3 months prior to enrollment, may be enrolled after a 3-month wash-out period where the maximum daily intake is limited to 800 IU vitamin D. Provision 2: an individual who consumed an average vitamin D dose higher than 2000 IU/day in the 3 months prior to enrollment, may be enrolled after a 6-month wash-out period where the maximum daily intake is limited to 800 IU vitamin D.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745263

Contacts
Contact: Heike A Bischoff-Ferrari, MD, DrPH (+41)44-2552699 heike.bischoff@usz.ch
Contact: Asa Müller, PhD (+41) 79 566 48 99 asa-mueller@do-health.eu

Locations
Austria
University of Innsbruck Recruiting
Innsbruck, Austria
Contact: Michael Blauth, MD       michael.blauth@i-med.ac.at   
Contact: Mariette Fasser    +43 (0)512 504 802 41    mariette.fasser@uki.at   
Principal Investigator: Michael Blauth, MD         
France
University of Toulouse - Centre de Recherche - Gérontopôle Hôpital La Grave Not yet recruiting
Toulouse, France
Contact: Bruno Vellas, MD       vellas.bruno@aol.com   
Contact: Agathe Milhet    (+33)561 77 64 70    milhet.a@chu-toulouse.fr   
Principal Investigator: Bruno Vellas, MD         
Germany
Charité Berlin Not yet recruiting
Berlin, Germany
Contact: Dieter Felsenberg, MD       dieter.felsenberg@charite.de   
Contact: Henrikje Boerst    (+49)30 84454745    hendrikje.boerst@charite.de   
Principal Investigator: Dieter Felsenberg, MD         
Portugal
University of Coimbra - Clínica Universitária de Reumatologia Not yet recruiting
Coimbra, Portugal
Contact: José daSilva, MD       jdasilva@ci.uc.pt   
Contact: Catia Duarte, MD    (+35)1 914 345 404    catiacmduarte@gmail.com   
Principal Investigator: José daSilva, MD, PhD         
Switzerland
Centre on Aging and Mobility, University of Zurich and City Hospital Waid Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Heike A Bischoff-Ferrari, MD, DrPH    (+41)44 2552699    Heike.Bischoff@usz.ch   
Contact: Asa Müller, PhD    (+41) 79 566 48 99    asa-mueller@do-health.eu   
Principal Investigator: Heike A Bischoff-Ferrari, MD, DrPH         
Basel University Recruiting
Basel, Switzerland
Contact: Reto Kressig, MD       RKressig@uhbs.ch   
Contact: Stephanie Bridenbaugh, MD    (+41) 61 326 47 51    Stephanie.Bridenbaugh@usb.ch   
Principal Investigator: Reto W Kressig, MD         
Principal Investigator: Norbert Suhm, MD         
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland
Contact: René Rizzoli, MD       Rene.Rizzoli@unige.ch   
Contact: Fanny Merminod    (+41) 22 372 99 74    fanny.merminod@hcuge.ch   
Principal Investigator: René Rizzoli, MD         
Sponsors and Collaborators
University of Zurich
Recruitment Partners
University of Zurich, Switzerland (Prof. Heike A. Bischoff-Ferrari, MD DrPH)
University of Geneva, Switzerland (Prof. René Rizzoli, MD)
University of Basel, Switzerland (Prof. Reto W. Kressig, MD and PD Norbert Suhm, MD)
University Hospital, Toulouse, France (Prof. Bruno Vellas, MD)
Charite University, Berlin, Germany
Medical University Innsbruck
University of Coimbra, Portugal (Prof. José daSilva, MD)
Other University Partners
University of Sheffield
University of Manchester, UK (Prof. David Felson, MD MPH)
Max Rubner University, Germany (Prof. Bernhard Watzl, PhD)
Technische Universität Dresden
Centre on Aging and Mobility, University of Zurich (Prof. Andreas Maetzel, MD PhD)
Impact Partner
International Osteoporosis Foundation (IOF; Prof. John Kanis, MD)
SME Partners
Ferrari Data Solutions GmBH, Switzerland (Stephen M. Ferrari; direct data entry platform)
Gut Pictures, Switzerland (Benno Gut; animated exercise video)
NOVAMEN, France (Sandrine Rival; logistic management partner)
Pharmalys, UK (Marieme Ba; monitoring partner)
Industry Partners
DSM Nutritional Products (Dr. Elisabeth Stöcklin PhD, Dr. Manfred Eggersdorfer PhD)
Nestlé (Michaela Höhne PhD, Irène Corthesy PhD)
Roche-Diagnostics (Monika Reuschling)
Funding within Framework 7 research program of the European Commission (project 278588)
Further collaborators and advisors at website do-health.eu
Investigators
Principal Investigator: Heike Bischoff Ferrari, Prof MD "Centre on Aging and Mobility" University of Zurich, University Hospital Zurich and City Hospital Waid.
  More Information

Additional Information:
No publications provided

Responsible Party: Heike Bischoff-Ferrari, Director, Centre on Aging and Mobility, University of Zurich
ClinicalTrials.gov Identifier: NCT01745263     History of Changes
Other Study ID Numbers: KEK-ZH-2012-0249, DO-HEALTH
Study First Received: December 6, 2012
Last Updated: March 8, 2013
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Portugal: National Authority of Medcines and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 19, 2014