Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Dietary Supplement: Vitamin D3 (cholecalciferol)

• Registration Number: NCT00599807
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: 2000 IU D3/day	Vitamin D3 (cholecalciferol)	2000 IU vitamin D3 taken orally each day for 2 years
2: 800 IU D3 / day	Vitamin D3 (cholecalciferol)	800 IU vitamin D3 taken orally each day for 2 years

Primary Outcome Measures

Name	Time	Method
pain and function of the operated and non-operated knee	0, 6,12,18, 24 months
rate of falls	0, 24 months

Secondary Outcome Measures

Name	Time	Method
number of teeth	0, 24 months
cost, health care utilization	0,6,12,18,24 months
facial skin keratosis (number and size)	0, 24 months
Quality of life	0,6,12,18,24
bone density, bone quality	0, 24 months
blood pressure	0,12,24 months
cognitive function	0, 24 months
depression, mental health	0,12,24 months
Number of upper respiratory infections and number of any infections	0, 6,12,28,24
bone metabolism	0,6,12,18,24
radiographic progression of the non-operated knee	0, 24 months
general pain	0,6,12,18,24 months
strength, balance, function, physical activity	0,6,12,18,24 months
body composition	0, 24 months
fasting blood glucose - insulin levels	0,12,24

Trial Locations

Locations (1)

University Hospital Zurich, Centre on Aging and Mobility; 🇨🇭 Zurich, ZH, Switzerland