This project was designed to optimizing vitamin D status in prefrail seniors age 70+ living at home and prevent their functional decline. We test 3 arms of monthly vitamin D supplementation. Intermittent dosing will improve adherence and simplify vitamin D supplementation.
We propose a double-blind, randomized controlled trial to test the effectiveness of a 1. Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily), 2. Active II (n=70): or a monthly standard vitamin D3 supplement dose combined with 25(OH)D (24'000 IU/month, equivalent to 800 IU daily PLUS 300 mcg 25(OH)D, equivalent to 10 mcg per day) 3. Control (n=70): compared to a standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily) All individuals will be advised to consume calcium from natural food sources in a daily dose of 600-800 mgs a day, including milk products. Maximal intake of supplemental calcium is restricted to 250 mg per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
60000 vitamin D3 orally and once per month
24000 Vitamin D3 orally and once per month
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, Switzerland
functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests)
Time frame: 6 and 12 months
Improving 25-hydroxyvitamin D levels in late winter and late summer - Percent of individuals reaching desirable 25-hydroxyvitamin D levels of at least 75 nmol/l in late winter and in late summer
Time frame: 6 and 12 months
Safety at baseline, 2 weeks, 6 months, 12 months • Serum calcium adjusted for albumin • Serum creatinine • Urinary calcium/creatinine ratio
Time frame: 2 weeks, 6 months, 12 months
Balance/Gait while walking combined with a cognitive task
Time frame: 12 months
Short Physical Performance Test Battery
Time frame: 6 months, 12 months
Timed 4 m walk
Time frame: 6 months, 12 months
Musculoskeletal pain assessed with the McGill pain map
Time frame: 6 months and 12 months
systolic and diastolic blood pressure, heart rate
Time frame: 6 month and 12 months
Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline)
Time frame: 12 months
grip strength
Time frame: 6 months and 12 months
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Bone density at the spine and hip, whole body
Time frame: 6 months and 12 months
incident vertebral fractures (iDXA morphometry)
Time frame: 12 months
muscle mass, incident sarcopenia
Time frame: 6 and 12 months
Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs.
Time frame: 12 months
Quality of life (SF 12 / EuroQuol)
Time frame: 6 months and 12 months
Rate of hospital admission (fall-related injury, infections, other)
Time frame: 12 months
Serum N-telopeptides and other markers of bone remodeling
Time frame: 6 months and 12 months
Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care
Time frame: 12 months