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

Launched by UNIVERSITY OF ZURICH · Dec 6, 2012

Keywords

ClinConnect Summary

The 3 primary treatment comparisons are:

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 cent...

Gender

ALL

Eligibility 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)
• • 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").