NCT00599807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

6.2 years

First QC Date

January 10, 2008

Last Update Submit

October 27, 2014

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • pain and function of the operated and non-operated knee

    0, 6,12,18, 24 months

  • rate of falls

    0, 24 months

Secondary Outcomes (15)

  • strength, balance, function, physical activity

    0,6,12,18,24 months

  • bone density, bone quality

    0, 24 months

  • body composition

    0, 24 months

  • blood pressure

    0,12,24 months

  • number of teeth

    0, 24 months

  • +10 more secondary outcomes

Study Arms (2)

1: 2000 IU D3/day

ACTIVE COMPARATOR

2000 IU vitamin D3 taken orally each day for 2 years

Dietary Supplement: Vitamin D3 (cholecalciferol)

2: 800 IU D3 / day

ACTIVE COMPARATOR

800 IU vitamin D3 taken orally each day for 2 years

Dietary Supplement: Vitamin D3 (cholecalciferol)

Interventions

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)

1: 2000 IU D3/day2: 800 IU D3 / day

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 38772577DERIVED

  • 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.

    PMID: 32542307DERIVED

  • 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.

    PMID: 31557423DERIVED

  • 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.

    PMID: 31152541DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Heike Bischoff-Ferrari, MD, MPH

    University Hospital Zurich, Centre on Aging and Mobility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 24, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

CH(1)