- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017354
Zurich Disability Prevention Trial (ZDPT)
August 21, 2015 updated by: University of Zurich
Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
We propose a double-blind, randomized controlled trial to test the effectiveness of a
- Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily),
- 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)
- 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
Enrollment (Actual)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Centre on Aging and Mobility
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age 70+
- Fall in the last 12 months before screening (with or without a fracture)
- Living at home (community-dwelling)
- Men or women
- Mobile with or without walking aid - have to be able to use public transportation to attend the clinical visits at the trial centre
- Score of at least 27 at the screening Folstein Mini Mental test + normal clock test
- 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.
- 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.
- Patient is willing to perform all study tests, attend all required office visits, and provide blood and urine samples.
Exclusion criteria:
- Serum calcium adjusted for albumin of > 2.6 nmol/l
- Pathologic fracture in the last year (except for fractures due to osteoporosis)
- Chemo therapy / Radiation due to cancer in the last year
- 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))
- Oral vitamin D intake of more than 800 IU per day
- Unwilling to stop calcium supplementation and vitamin D supplementation during the trial (maximal calcium supplement intake 250mg/d; no additional vitamin D supplementation)
- Severe visual or hearing impairment
- Unwilling or unable to take study medication
- 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)
- BMI >= 40
- Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance Cockcroft and Gault)
- Malabsorption syndrome (celiac diseases, inflammatory bowl disease)
- Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
- kidney stone in the last 10 years
- Abnormal indices of calcium metabolism, uncontrolled hypocalcemia.
- Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
- Patient is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
- Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than two months per year
- Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
- M. Paget (Ostitis deformans)
- inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis arthritis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-dose vitamin D3
monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily)
|
60000 vitamin D3 orally and once per month
24000 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)
|
24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
|
Active Comparator: standard vitamin D
standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)
|
60000 vitamin D3 orally and once per month
24000 Vitamin D3 orally and once per month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 weeks, 6 months, 12 months
|
Balance/Gait while walking combined with a cognitive task
Time Frame: 12 months
|
12 months
|
Short Physical Performance Test Battery
Time Frame: 6 months, 12 months
|
6 months, 12 months
|
Timed 4 m walk
Time Frame: 6 months, 12 months
|
6 months, 12 months
|
Musculoskeletal pain assessed with the McGill pain map
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
systolic and diastolic blood pressure, heart rate
Time Frame: 6 month and 12 months
|
6 month and 12 months
|
Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline)
Time Frame: 12 months
|
12 months
|
grip strength
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Bone density at the spine and hip, whole body
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
incident vertebral fractures (iDXA morphometry)
Time Frame: 12 months
|
12 months
|
muscle mass, incident sarcopenia
Time Frame: 6 and 12 months
|
6 and 12 months
|
Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs.
Time Frame: 12 months
|
12 months
|
Quality of life (SF 12 / EuroQuol)
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Rate of hospital admission (fall-related injury, infections, other)
Time Frame: 12 months
|
12 months
|
Serum N-telopeptides and other markers of bone remodeling
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heike Bischoff Ferrari, MD, MPH, University Hospital Zurich, Centre on Aging and Mobility
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 19, 2009
First Submitted That Met QC Criteria
November 19, 2009
First Posted (Estimate)
November 20, 2009
Study Record Updates
Last Update Posted (Estimate)
August 24, 2015
Last Update Submitted That Met QC Criteria
August 21, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK39/09
- 2009DR2248 (Other Identifier: Swissmedic (Swiss Agency for Therapeutic Products))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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