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| ID | Type | Description | Link |
|---|---|---|---|
| 2007DR4347 | Other Identifier | Swiss Agency for Therapeutic Products (Swissmedic) |
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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
| Tufts University | OTHER |
| Boston University | OTHER |
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This is a 2-year double-blind randomized controlled trial in 287 community-dwelling individuals age 60 years or older undergoing uni-lateral total knee replacement due to severe OA of the knee.We compare an oral dose of 2000 IU vitamin D3 per day to 800 IU. The primary endpoints are pain and disability related to rehabilitation of the operated knee,and related to the expected high prevalence of OA in the contra-lateral knee. Secondary endpoints are change in 25(OH)D levels, muscle strength, balance, lower extremity function, the rate of falls, bone density and bone quality, bone metabolism, general pain, fall-related fractures, body composition, blood-pressure, major cardiovascular events, blood glucose-insulin levels, executive cognitive function, rate of upper respiratory tract infections / all infections, tooth loss, dental health, health care utilization, number and size of facial skin keratosis, and radiographic progression of the non-operated knee. Pain and disability will be assessed by the pain and function subscales of the Western Ontario- McMaster Universities Osteoarthritis Index (WOMAC). Randomization will be stratified by WOMAC function prior to surgery, radiological evidence for OA in the contra-lateral knee, and hospital. Clinical visits will take place at baseline (6-8 weeks after TKR), at 6, 12, 18 and 24 months of treatment. In addition, all individuals will receive a phone call every 2 month to assess adverse outcomes and compliance to treatment, supported by a hotline for immediate report of adverse events.
Statistical power: We expect more than 80% power with 200 participants completing their 24 month follow-up, and 260 participants completing their 12 month follow-up.
This is a trial with medicinal product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: 2000 IU D3/day | Active Comparator | 2000 IU vitamin D3 taken orally each day for 2 years |
|
| 2: 800 IU D3 / day | Active Comparator | 800 IU vitamin D3 taken orally each day for 2 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Dietary Supplement | the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain and function of the operated and non-operated knee | 0, 6,12,18, 24 months | |
| rate of falls | 0, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| strength, balance, function, physical activity | 0,6,12,18,24 months | |
| bone density, bone quality | 0, 24 months | |
| body composition |
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Inclusion Criteria:
Exclusion Criteria:
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| 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. | |
| 32542307 | Derived | Abderhalden LA, Meyer S, Dawson-Hughes B, Orav EJ, Meyer U, de Godoi Rezende Costa Molino C, Theiler R, Stahelin HB, Ruschitzka F, Egli A, Forman JP, Willett WC, Bischoff-Ferrari HA. Effect of daily 2000 IU versus 800 IU vitamin D on blood pressure among adults age 60 years and older: a randomized clinical trial. Am J Clin Nutr. 2020 Sep 1;112(3):527-537. doi: 10.1093/ajcn/nqaa145. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 0, 24 months |
| blood pressure | 0,12,24 months |
| number of teeth | 0, 24 months |
| cost, health care utilization | 0,6,12,18,24 months |
| facial skin keratosis (number and size) | 0, 24 months |
| cognitive function | 0, 24 months |
| depression, mental health | 0,12,24 months |
| fasting blood glucose - insulin levels | 0,12,24 |
| Number of upper respiratory infections and number of any infections | 0, 6,12,28,24 |
| bone metabolism | 0,6,12,18,24 |
| radiographic progression of the non-operated knee | 0, 24 months |
| general pain | 0,6,12,18,24 months |
| Quality of life | 0,6,12,18,24 |
| 31557423 | Derived | Freystaetter G, Fischer K, Orav EJ, Egli A, Theiler R, Munzer T, Felson DT, Bischoff-Ferrari HA. Total Serum Testosterone and Western Ontario and McMaster Universities Osteoarthritis Index Pain and Function Among Older Men and Women With Severe Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1511-1518. doi: 10.1002/acr.24074. |
| 31152541 | Derived | Schietzel S, Fischer K, Brugger P, Orav EJ, Renerts K, Gagesch M, Freystaetter G, Stahelin HB, Egli A, Bischoff-Ferrari HA. Effect of 2000 IU compared with 800 IU vitamin D on cognitive performance among adults age 60 years and older: a randomized controlled trial. Am J Clin Nutr. 2019 Jul 1;110(1):246-253. doi: 10.1093/ajcn/nqz081. |
| D012216 |
| Rheumatic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |