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Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599807
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : October 28, 2014
Harvard School of Public Health
Tufts University
Boston University
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Vitamin D3 (cholecalciferol) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Vitamin D in Secondary Prevention of Knee Osteoarthritis: A Double-blind Randomized Controlled Trial
Study Start Date : January 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1: 2000 IU D3/day
2000 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)

Active Comparator: 2: 800 IU D3 / day
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)

Primary Outcome Measures :
  1. pain and function of the operated and non-operated knee [ Time Frame: 0, 6,12,18, 24 months ]
  2. rate of falls [ Time Frame: 0, 24 months ]

Secondary Outcome Measures :
  1. strength, balance, function, physical activity [ Time Frame: 0,6,12,18,24 months ]
  2. bone density, bone quality [ Time Frame: 0, 24 months ]
  3. body composition [ Time Frame: 0, 24 months ]
  4. blood pressure [ Time Frame: 0,12,24 months ]
  5. number of teeth [ Time Frame: 0, 24 months ]
  6. cost, health care utilization [ Time Frame: 0,6,12,18,24 months ]
  7. facial skin keratosis (number and size) [ Time Frame: 0, 24 months ]
  8. cognitive function [ Time Frame: 0, 24 months ]
  9. depression, mental health [ Time Frame: 0,12,24 months ]
  10. fasting blood glucose - insulin levels [ Time Frame: 0,12,24 ]
  11. Number of upper respiratory infections and number of any infections [ Time Frame: 0, 6,12,28,24 ]
  12. bone metabolism [ Time Frame: 0,6,12,18,24 ]
  13. radiographic progression of the non-operated knee [ Time Frame: 0, 24 months ]
  14. general pain [ Time Frame: 0,6,12,18,24 months ]
  15. Quality of life [ Time Frame: 0,6,12,18,24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Unilateral knee replacement due to knee osteoarthritis
  • Age 60+ years
  • German language skills
  • community dwelling

Exclusion Criteria:

  • Bi-lateral knee replacement or hip replacement planned in the trial period, or in the previous 6 months
  • Chronic steroid intake
  • Serum calcium corrected for serum albumin > 2.6 mmol/l
  • GFR < 30 ml/min
  • Severe visual or hearing impairment
  • Inflammatory arthritis
  • Malabsorption
  • High alcohol intake
  • Sarcoidosis, primary hyperparathyroidism
  • History of kidney stones, lymphoma
  • Chemotherapy for cancer in the previous 12 months
  • Hemiplegia
  • Morbus Parkinson
  • Unable to walk 3 meters prior to surgery
  • Bisphosphonate, parathyroid hormone , fluoride or calcitonine therapy in the last 6 months
  • Zolendronate in the last year
  • M. Paget (Ostitis deformans)
  • Vitamin D3 intake more than 800IU/d over more than 1 month
  • stay on a sunny location for more than 6 weeks per year
  • heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599807

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University Hospital Zurich, Centre on Aging and Mobility
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Harvard School of Public Health
Tufts University
Boston University
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Principal Investigator: Heike Bischoff-Ferrari, MD, MPH University Hospital Zurich, Centre on Aging and Mobility
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Zurich Identifier: NCT00599807    
Other Study ID Numbers: PP00B-114864
2007DR4347 ( Other Identifier: Swiss Agency for Therapeutic Products (Swissmedic) )
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents