Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D to Slow Progression of Knee Osteoarthritis

NCT00306774

Osteoarthritis, Knee

COMPLETED PHASE2

Effects of Vitamin D Supplementation on Postoperative Rehabilitation in Hip and Knee Osteoarthritis Patients

NCT06747559

Osteoarthritis of the Hip or Knee Joint Arthroplasty

NOT_YET_RECRUITING NA

Evaluating Vitamin D3 Supplement on Post-Op Outcomes

NCT04177758

Knee Osteoarthritis

COMPLETED PHASE4

VItamin D Effect on Osteoarthritis Study

NCT01176344

Osteoarthritis, Knee

COMPLETED PHASE3

Vitamin D Supplementation in Knee Osteoarthritis

NCT04121533

Osteoarthritis, Knee Vitamin D Supplementation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: 2000 IU D3/day

2000 IU vitamin D3 taken orally each day for 2 years

Group Type ACTIVE_COMPARATOR

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)

2: 800 IU D3 / day

800 IU vitamin D3 taken orally each day for 2 years

Group Type ACTIVE_COMPARATOR

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D3 (cholecalciferol)

the intervention is a dietary supplement comparing the current standard (800 IU) to the current safe upper limit (2000 IU)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No