study for healthy ageing

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2152

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

(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)