Community-dwelling Seniors Clinical Trial
— ZDPTOfficial title:
Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home
| Verified date | August 2015 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | December 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Centre on Aging and Mobility | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests) | 6 and 12 months | No | |
| Primary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | Balance/Gait while walking combined with a cognitive task | 12 months | No | |
| Secondary | Short Physical Performance Test Battery | 6 months, 12 months | No | |
| Secondary | Timed 4 m walk | 6 months, 12 months | No | |
| Secondary | Musculoskeletal pain assessed with the McGill pain map | 6 months and 12 months | No | |
| Secondary | systolic and diastolic blood pressure, heart rate | 6 month and 12 months | No | |
| Secondary | Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline) | 12 months | No | |
| Secondary | grip strength | 6 months and 12 months | No | |
| Secondary | Bone density at the spine and hip, whole body | 6 months and 12 months | No | |
| Secondary | incident vertebral fractures (iDXA morphometry) | 12 months | No | |
| Secondary | muscle mass, incident sarcopenia | 6 and 12 months | No | |
| Secondary | Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs. | 12 months | No | |
| Secondary | Quality of life (SF 12 / EuroQuol) | 6 months and 12 months | No | |
| Secondary | Rate of hospital admission (fall-related injury, infections, other) | 12 months | No | |
| Secondary | Serum N-telopeptides and other markers of bone remodeling | 6 months and 12 months | No | |
| Secondary | Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care | 12 months | No |