Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009DR2248 | Other Identifier | Swissmedic (Swiss Agency for Therapeutic Products) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
We propose a double-blind, randomized controlled trial to test the effectiveness of a
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose vitamin D3 | Experimental | monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily) |
|
| standard vitamin D + 25(OH)D | Experimental | 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) |
|
| standard vitamin D | Active Comparator | standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hidroferol® (ES) | Drug | 24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heike Bischoff Ferrari, MD, MPH | University Hospital Zurich, Centre on Aging and Mobility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Centre on Aging and Mobility | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38772577 | Derived | Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413. | |
| 26747333 | Derived | Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, Staehelin HB, Meyer OW, Theiler R, Dick W, Willett WC, Egli A. Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):175-83. doi: 10.1001/jamainternmed.2015.7148. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ViDe3 (CH) | Dietary Supplement | 60000 vitamin D3 orally and once per month |
|
| ViDe3 (CH) | Dietary Supplement | 24000 Vitamin D3 orally and once per month |
|
| 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |