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Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

NCT00599807 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2014-10-28

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Tufts University

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Heike Bischoff-Ferrari, MD, MPH · University Hospital Zurich, Centre on Aging and Mobility

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599807 on ClinicalTrials.gov