Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Zurich
Sponsor:
Collaborators:
Harvard School of Public Health
Tufts University
Boston University
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00599807
First received: January 10, 2008
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Dietary Supplement: Vitamin D3 (cholecalciferol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Vitamin D in Secondary Prevention of Knee Osteoarthritis: A Double-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • pain and function of the operated and non-operated knee [ Time Frame: 0, 6,12,18, 24 months ] [ Designated as safety issue: No ]
  • rate of falls [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • strength, balance, function, physical activity [ Time Frame: 0,6,12,18,24 months ] [ Designated as safety issue: No ]
  • bone density, bone quality [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 0,12,24 months ] [ Designated as safety issue: No ]
  • number of teeth [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • cost, health care utilization [ Time Frame: 0,6,12,18,24 months ] [ Designated as safety issue: No ]
  • facial skin keratosis (number and size) [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • cognitive function [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • depression, mental health [ Time Frame: 0,12,24 months ] [ Designated as safety issue: No ]
  • fasting blood glucose - insulin levels [ Time Frame: 0,12,24 ] [ Designated as safety issue: No ]
  • Number of upper respiratory infections and number of any infections [ Time Frame: 0, 6,12,28,24 ] [ Designated as safety issue: No ]
  • bone metabolism [ Time Frame: 0,6,12,18,24 ] [ Designated as safety issue: No ]
  • radiographic progression of the non-operated knee [ Time Frame: 0, 24 months ] [ Designated as safety issue: No ]
  • general pain [ Time Frame: 0,6,12,18,24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 0,6,12,18,24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 287
Study Start Date: January 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599807

Contacts
Contact: Heike A Bischoff-Ferrari, MD, DrPH +41 (0)44 255 9498 Heike.Bischoff@usz.ch
Contact: Sandra Neukom +41(0)442552699

Locations
Switzerland
University Hospital Zurich, Centre on Aging and Mobility Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Harvard School of Public Health
Tufts University
Boston University
Investigators
Principal Investigator: Heike Bischoff-Ferrari, MD, MPH University Hospital Zurich, Centre on Aging and Mobility
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00599807     History of Changes
Other Study ID Numbers: PP00B-114864, 2007DR4347
Study First Received: January 10, 2008
Last Updated: January 18, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014