ZDPT: Zurich Disability Prevention Trial
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
We propose a double-blind, randomized controlled trial to test the effectiveness of a
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Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily),
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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)
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: High-dose vitamin D3 monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily) |
Dietary Supplement: ViDe3 (CH)
60000 vitamin D3 orally and once per month
|
Experimental: standard vitamin D + 25(OH)D 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) |
Drug: Hidroferol® (ES)
24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
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Active Comparator: standard vitamin D standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily) |
Dietary Supplement: ViDe3 (CH)
24000 Vitamin D3 orally and once per month
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- systolic and diastolic blood pressure, heart rate [6 month and 12 months]
- Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline) [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]
Eligibility Criteria
Criteria
Inclusion criteria:
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Age 70+
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Fall in the last 12 months before screening (with or without a fracture)
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Living at home (community-dwelling)
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Men or women
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Mobile with or without walking aid - have to be able to use public transportation to attend the clinical visits at the trial centre
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Score of at least 27 at the screening Folstein Mini Mental test + normal clock test
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Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving a written informed consents.
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Patient meets the entry minimal requirements based on routine clinical laboratory safety screening tests and the Folstein mini mental status (score 27+ required) performed at the Screening Visit.
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Patient is willing to perform all study tests, attend all required office visits, and provide blood and urine samples.
Exclusion criteria:
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Serum calcium adjusted for albumin of > 2.6 nmol/l
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Pathologic fracture in the last year (except for fractures due to osteoporosis)
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Chemo therapy / Radiation due to cancer in the last year
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Treatment which has an effect on bone metabolism (e.g. bisphosphonate, PTH, calcitonin, chronic cortisone intake > XYmg/day for more than XY month/years (except for inhalation and sporadic infiltration))
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Oral vitamin D intake of more than 800 IU per day
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Unwilling to stop calcium supplementation and vitamin D supplementation during the trial (maximal calcium supplement intake 250mg/d; no additional vitamin D supplementation)
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Severe visual or hearing impairment
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Unwilling or unable to take study medication
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Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
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BMI >= 40
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Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance Cockcroft and Gault)
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Malabsorption syndrome (celiac diseases, inflammatory bowl disease)
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Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
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kidney stone in the last 10 years
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Abnormal indices of calcium metabolism, uncontrolled hypocalcemia.
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Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
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Patient is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
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Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than two months per year
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Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
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- Paget (Ostitis deformans)
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inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis arthritis)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital Zurich, Centre on Aging and Mobility | Zurich | ZH | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
Investigators
- Principal Investigator: Heike Bischoff Ferrari, MD, MPH, University Hospital Zurich, Centre on Aging and Mobility
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KEK39/09
- 2009DR2248