Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599807
• Other study ID #: PP00B-114864
• Secondary ID: 2007DR4347
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: October 27, 2014
• Start date: January 2008
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Centre on Aging and Mobility	Zurich	ZH

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Boston University, Harvard School of Public Health, Tufts University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain and function of the operated and non-operated knee		0, 6,12,18, 24 months	No
Primary	rate of falls		0, 24 months	No
Secondary	strength, balance, function, physical activity		0,6,12,18,24 months	No
Secondary	bone density, bone quality		0, 24 months	No
Secondary	body composition		0, 24 months	No
Secondary	blood pressure		0,12,24 months	No
Secondary	number of teeth		0, 24 months	No
Secondary	cost, health care utilization		0,6,12,18,24 months	No
Secondary	facial skin keratosis (number and size)		0, 24 months	No
Secondary	cognitive function		0, 24 months	No
Secondary	depression, mental health		0,12,24 months	No
Secondary	fasting blood glucose - insulin levels		0,12,24	No
Secondary	Number of upper respiratory infections and number of any infections		0, 6,12,28,24	No
Secondary	bone metabolism		0,6,12,18,24	No
Secondary	radiographic progression of the non-operated knee		0, 24 months	No
Secondary	general pain		0,6,12,18,24 months	No
Secondary	Quality of life		0,6,12,18,24	No