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Knee OsteoarthritisPhase 4NCT00599807

Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

A Phase 4 study testing Vitamin D3 (cholecalciferol) in people with Knee Osteoarthritis, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Vitamin D3 (cholecalciferol)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
1 siteSwitzerland
Study dates
Jan 2008to Mar 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unilateral knee replacement due to knee osteoarthritis
  • Age 60+ years
  • German language skills
  • community dwelling

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich, Centre on Aging and Mobility

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Being tested
Vitamin D3 (cholecalciferol)
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 (cholecalciferol)Dietary supplement

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

Study groups in NCT00599807
Study groupRoleWhat they receive
1: 2000 IU D3/dayActive comparator2000 IU vitamin D3 taken orally each day for 2 years
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol)
2: 800 IU D3 / dayActive comparator800 IU vitamin D3 taken orally each day for 2 years
Receives: Dietary Supplement: Vitamin D3 (cholecalciferol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain and function of the operated and non-operated knee

    Measured: 0, 6,12,18, 24 months

  2. rate of falls

    Measured: 0, 24 months

Secondary outcomes (15)

  1. strength, balance, function, physical activity

    Measured: 0,6,12,18,24 months

  2. bone density, bone quality

    Measured: 0, 24 months

  3. body composition

    Measured: 0, 24 months

  4. blood pressure

    Measured: 0,12,24 months

  5. number of teeth

    Measured: 0, 24 months

  6. cost, health care utilization

    Measured: 0,6,12,18,24 months

  7. facial skin keratosis (number and size)

    Measured: 0, 24 months

  8. cognitive function

    Measured: 0, 24 months

  9. depression, mental health

    Measured: 0,12,24 months

  10. fasting blood glucose - insulin levels

    Measured: 0,12,24

  11. Number of upper respiratory infections and number of any infections

    Measured: 0, 6,12,28,24

  12. bone metabolism

    Measured: 0,6,12,18,24

  13. radiographic progression of the non-operated knee

    Measured: 0, 24 months

  14. general pain

    Measured: 0,6,12,18,24 months

  15. Quality of life

    Measured: 0,6,12,18,24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599807
Sponsor's protocol ID
PP00B-114864
Other IDs
2007DR4347
Status last verified
Oct 2014
First submitted
10 Jan 2008
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413.

    PubMed 38772577

  • Abderhalden LA, Meyer S, Dawson-Hughes B, Orav EJ, Meyer U, de Godoi Rezende Costa Molino C, Theiler R, Stahelin HB, Ruschitzka F, Egli A, Forman JP, Willett WC, Bischoff-Ferrari HA. Effect of daily 2000 IU versus 800 IU vitamin D on blood pressure among adults age 60 years and older: a randomized clinical trial. Am J Clin Nutr. 2020 Sep 1;112(3):527-537. doi: 10.1093/ajcn/nqaa145.

    PubMed 32542307

  • Freystaetter G, Fischer K, Orav EJ, Egli A, Theiler R, Munzer T, Felson DT, Bischoff-Ferrari HA. Total Serum Testosterone and Western Ontario and McMaster Universities Osteoarthritis Index Pain and Function Among Older Men and Women With Severe Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1511-1518. doi: 10.1002/acr.24074.

    PubMed 31557423

  • Schietzel S, Fischer K, Brugger P, Orav EJ, Renerts K, Gagesch M, Freystaetter G, Stahelin HB, Egli A, Bischoff-Ferrari HA. Effect of 2000 IU compared with 800 IU vitamin D on cognitive performance among adults age 60 years and older: a randomized controlled trial. Am J Clin Nutr. 2019 Jul 1;110(1):246-253. doi: 10.1093/ajcn/nqz081.

    PubMed 31152541

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D3 (cholecalciferol) in people with Knee Osteoarthritis, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain and function of the operated and non-operated knee (time frame: 0, 6,12,18, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00599807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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