Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

University of Zurich (UZH)

Status and phase

Completed

Phase 4

Conditions

Knee Osteoarthritis

Treatments

Dietary Supplement: Vitamin D3 (cholecalciferol)

Study type

Interventional

Funder types

Other

Identifiers

NCT00599807

PP00B-114864

2007DR4347 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

273 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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