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Completed

NCT Number: NCT00599807

Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

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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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Boston University
  • Harvard School of Public Health (HSPH)
  • Tufts University

Registry information

Official study title

Role of Vitamin D in Secondary Prevention of Knee Osteoarthritis: A Double-blind Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2008
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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