Zurich Disability Prevention Trial
- Conditions
- Community-dwelling SeniorsHistory of a Fall in the Previous 12 Months
- Interventions
- Dietary Supplement: ViDe3 (CH)Drug: Hidroferol® (ES)
- Registration Number
- NCT01017354
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose vitamin D3 ViDe3 (CH) monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily) standard vitamin D ViDe3 (CH) standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily) standard vitamin D + 25(OH)D Hidroferol® (ES) 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)
- Primary Outcome Measures
Name Time Method functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests) 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 6 and 12 months
- Secondary Outcome Measures
Name Time Method Safety at baseline, 2 weeks, 6 months, 12 months • Serum calcium adjusted for albumin • Serum creatinine • Urinary calcium/creatinine ratio 2 weeks, 6 months, 12 months Balance/Gait while walking combined with a cognitive task 12 months Short Physical Performance Test Battery 6 months, 12 months Timed 4 m walk 6 months, 12 months Musculoskeletal pain assessed with the McGill pain map 6 months and 12 months Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline) 12 months systolic and diastolic blood pressure, heart rate 6 month and 12 months grip strength 6 months and 12 months Bone density at the spine and hip, whole body 6 months and 12 months incident vertebral fractures (iDXA morphometry) 12 months muscle mass, incident sarcopenia 6 and 12 months Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs. 12 months Quality of life (SF 12 / EuroQuol) 6 months and 12 months Rate of hospital admission (fall-related injury, infections, other) 12 months Serum N-telopeptides and other markers of bone remodeling 6 months and 12 months Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care 12 months
Trial Locations
- Locations (1)
University Hospital Zurich, Centre on Aging and Mobility
🇨🇭Zurich, ZH, Switzerland