Zurich Disability Prevention Trial

Phase 2

Completed

• Conditions: Community-dwelling Seniors; History 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.

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-01
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

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
Short Physical Performance Test Battery	6 months, 12 months
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
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