healthy ageing, functional decline
Conditions
Interventions
Product Name: Vitamin D3
Product Code: 5011574
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: IU international unit(s)
Concentration typ
Sponsors
University Hospital of Zurich and City Hospital Waid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Mini Mental State Examination Score of at least 24 - Living in the community - Sufficiently mobile to come to the study centre, to walk 10 meters with or without walking aid and to get in and out of a chair without help - Able to swallow study medication - Able and willing to participate, sign informed consent (including consent to analyze all samples until withdrawal) and cooperate with study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2152
Exclusion criteria
Exclusion criteria: (1) Consumption of more than 1000 IU vitamin D/day in the 6 month prior to enrolment, and/or a bolus of 300'000 IU vitamin D or more in the 12 month prior to enrolment, 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 (2) Unwillingness to limit calcium supplement dose to 500 mg per day for the duration of the trial (3) Taking omega-3 fat supplements and unwilling to forgo their use for the duration of the trial (4) 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 (5) 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) (6) 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 (7) Severe renal impairment (creatinine clearance = 15 ml/min) or dialysis, hypercalcaemia (> 2.6 mmol/l) (8) Hemiplegia or other severe gait impairment (9) History of hypo- or primary hyper-parathyroidism (10) Severe liver disease (11) History of granulomatous diseases (i.e. tubercolosis, sarcoidosis) (12) Major visual or hearing impairment or other serious illness that would preclude participation (13) Living with a partner who is enrolled in DO-HEALTH (we exclude couples) (14) Living in assisted living situations or a nursing home (15) Temporary exclusion: acute fracture in the last 6 weeks (16) Epilepsy and/or use of anti-epileptic drugs (17) Individuals who fell more than 3 times in the last month (18) Osteodystrophia deformans (M. Paget, Paget's disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Broad Goals The DO-HEALTH trial is designed to establish evidence for the role of vitamin D, omega-3 fatty acids, and a simple exercise program, both individually and as a combined intervention, in chronic disease prevention at older age. Objectives Main Objectives: • To improve healthy ageing in European seniors • To reduce healthcare costs via the implementation of effective and broadly applicable disease prevention interventions;Secondary Objective: Scientific Objectives: • To test whether 2000 IU vitamin D reduces risk of chronic disease in seniors compared to placebo • To test whether 1 g of marine omega-3 fatty acids (EPA+DHA) reduces the risk of chronic disease in seniors compared to placebo • To test whether a simple home exercise program reduces the risk of chronic disease in seniors compared to control (sham exercise performed 30 minutes 3 times a week) • To test whether there is an additive value of the 3 interventions combined as a multi-modal intervention in the reduction of chronic disease in seniors • To assess the comparative effectiveness of the interventions and to test whether and to what degree adherence modulates the effect of the 3 interventions on risk reduction of chronic disease in seniors • To assess the cost-benefit of the 3 interventions individually and in combination as a multi-modal intervention based on an objective health economic mode ;Primary end point(s): Primary Endpoints: (1) Bone: Incident non-vertebral fractures over 36 months (confirmed by X-ray or medical reports) (2) Muscle: Functional decline (assessed by Short Physical Performance Test Battery) (3) Cardiovascular: Systolic and diastolic blood pressure change (4) Brain: Cognitive decline (assessed by Mini Mental State Examination) (5) Immunity: rate of any infection;Timepoint(s) of evaluation of this end point: The evaluation of the primary endpoints will perform at baseline and then at the annual visits including the final visit after three years. The num | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: To support the primary endpoints and extend to other organ systems: (1) Bone: incidence of hip fractures, incidence of new vertebral fractures (vertebral morphometry obtained with DEXA measurements), incidence of total fractures – (DEXA measurements), risk of bone mineral density decrease in the spine and hip (assessed by DEXA measurements) (2) Muscle: rate of falling (rate of any low trauma fall, rate of injurious falls, number of persons who fell), reaction time and grip strength, incidence of muscle mass decrease at the upper and lower extremities (DEXA measurements), musculoskeletal pain, dual tasking 10 meter gait speed (3) Cardiovascular: risk of incident hypertension (4) Brain: mental health decline, incident depression, dual tasking gait variability (5) Immunity: rate of any upper respiratory infection, incident flu-like illness, incident severe infections that lead to hospital admission (6) Bone/Cartilage: Arthritis: primary outcome for osteoarthritis will be severity of knee pain (KOOS) in those with symptomatic knee osteoarthritis, secondary outcomes for osteoarthritis will be: rate of knee buckling, NSAID use because of knee pain; number of joints with pain (7) Dental: decline in oral health, tooth loss (8) Gastro-intestinal: gastro-intestinal symptoms based on Rome III questionnaire (9) Glucose-metabolic: fasting glucose and insulin levels, QUICKI and HOMA index, body composition and increase in body fat in the trunk and extremities by DEXA (10) Kidney: decline in kidney function – by blood creatinine levels and estimated GFR (11) Global Health: quality of life, incident frailty, incident disability regarding activities of daily living, incident nursing home admissions, rate of acute hospital admissions, mortality Exploratory Endpoints: To support the primary endpoints, but have limited statistical power: (1) Bone: Incident repeat fractures (any non-vertebral in all participants, vertebral fractures and tota | — |
Countries
France, Germany, Portugal, Switzerland
Contacts
Public ContactHeike A. Bischoff-Ferrari
University Hospital of Zurich and City Hospital Waid
Outcome results
None listed