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Sponsors and Collaborators: |
University of Zurich Harvard School of Public Health Tufts University Boston University |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00599807 |
This is a 2-year double-blind randomized controlled trial in 380 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 cardio-vacular 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.
This is a trial with medicinal product.
Condition | Intervention | Phase |
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Knee Osteoarthritis |
Dietary Supplement: Vitamin D3 (cholecalciferol) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Role of Vitamin D in Secondary Prevention of Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial |
Estimated Enrollment: | 380 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: 2000 IU D3/day: Active Comparator
2000 IU vitamin D3 taken orally each day for 2 years
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Dietary Supplement: Vitamin D3 (cholecalciferol)
the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)
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2: 800 IU D3 / day: Active Comparator
800 IU vitamin D3 taken orally each day for 2 years
|
Dietary Supplement: Vitamin D3 (cholecalciferol)
the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)
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Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heike A Bischoff-Ferrari, MD, MPH | +41 (0)44 255 9498 | Heike.Bischoff@usz.ch |
Contact: Sandra Neukom | +41(0)442552699 |
Switzerland | |
University Hospital Zurich | Recruiting |
Zurich, Switzerland, 8091 |
Principal Investigator: | Heike A Bischoff-Ferrari, MD, MPH | UniversitaetsSpital Zuerich |
Responsible Party: | University Hospital Zurich ( Prof. Heike A. Bischoff-Ferrari, MD, MPH ) |
Study ID Numbers: | PP00B-114864, 2007DR4347, PP00B-114864 |
Study First Received: | January 10, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00599807 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Cholecalciferol Osteoarthritis Joint Diseases Trace Elements Bone Density Conservation Agents Rheumatic Diseases Osteoarthritis, Knee |
Vitamin D Musculoskeletal Diseases Arthritis Vitamins Neoplasm Metastasis Micronutrients |
Cholecalciferol Osteoarthritis Joint Diseases Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Rheumatic Diseases |
Pharmacologic Actions Osteoarthritis, Knee Vitamin D Musculoskeletal Diseases Arthritis Vitamins Micronutrients |