Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000495022
Ethics application status
Approved
Date submitted
9/06/2010
Date registered
16/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does vitamin D supplementation prevent progression of knee osteoarthritis? A randomised controlled trial
Scientific title
Effects of vitamin D supplementation on knee pain, knee structural change, and lower limb muscle strength in patients with symptomatic knee osteoarthritis: A randomised, double-blind, placebo-controlled trial
Secondary ID [1] 251977 0
Nil
Universal Trial Number (UTN)
Trial acronym
VIDEO (The VItamin D Effect on Osteoarthritis) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 257546 0
Condition category
Condition code
Musculoskeletal 257707 257707 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol (vitamin D3) tablets given once monthly for 2 years
Intervention code [1] 256635 0
Treatment: Drugs
Intervention code [2] 256636 0
Prevention
Comparator / control treatment
The control arm will receive an identical inert placebo (1.25 mg microcrystalline cellulose tablet).
Control group
Placebo

Outcomes
Primary outcome [1] 258606 0
Loss of knee cartilage volume, as assessed by magnetic resonance imaging (MRI).
Timepoint [1] 258606 0
MRI assessment will occur at month 0 (baseline) and 24.
Secondary outcome [1] 264506 0
The progression of knee cartilage defects and enlargement of tibial bone area, as assessed by MRI;
Timepoint [1] 264506 0
MRI assessment will occur at month 0 (baseline) and 24.
Secondary outcome [2] 264527 0
Loss of lower limb muscle strength, measured by dynamometry;
Timepoint [2] 264527 0
Muscle strength assessment will occur at month 0, 3, 6, 12 and 24.
Secondary outcome [3] 264528 0
Progress of knee pain, assessed by The Western Ontario & McMaster Universities Arthritis Index (WOMAC).
Timepoint [3] 264528 0
Knee pain assessment will occur at month 0, 3, 6, 12 and 24.

Eligibility
Key inclusion criteria
1) Age 50-79 years old;
2) Men and women with symptomatic knee OA for at least 6 months with a pain visual analogue scale (VAS) of at least 20 mm;
3) Meet the America College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis (OA);
4) Have an ACR functional class rating of I, II and III;
5) Have relatively good health (0-2 according to the investigator’s global assessment of disease status on a 5-point Likert scale, range 0 [very well] to 4 [very poor]);
6) Have serum vitamin D level of >12.5 nmol/L and <60 nmol/L; and
7) Is able to read, speak and understand English, capable of understanding the study requirements and willing to co-operate with the study instructions.
Minimum age
50 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients with severe radiographic knee OA (grade 3 according to Altman’s atlas);
2) Patients with severe knee pain (on standing more than 80 mm on a 100-mm VAS);
3) Any contra-indication to having an MRI;
4) Patients with rheumatoid arthritis, psoratic arthritis, lupus, or cancer;
5) Patients with severe cardiac or renal function impairment
6) Patients with hypersensitivity to vitamin D;
7) Patients with any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy);
8) having significant trauma to the knees including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the study;
9) having anticipated need for knee or hip surgery in the next 2 years;
10) having taken Vitamin D supplements in last 30 days;
11) having taken an investigational drug in last 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will recruit subjects with symptomatic knee OA by using a combined strategy, including collaboration with general practitioners, specialist rheumatologists, and orthopaedic surgeons, as well as advertising through local media.

Allocation concealment will be ensured by the used of identical inert placebo, and the use of a central automated allocation procedure (consecutively numbered, sealed and opaque envelopes will be used), with security in place to ensure allocation data cannot be accessed or influenced by any person. Thus the randomized controlled trial (RCT) will be double blind.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of participants will be based on computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257116 0
Government body
Name [1] 257116 0
National Health & Medical Research Council (NHMRC)
Country [1] 257116 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute, University of Tasmania
Address
17 Liverpool St, Hobart 7000, Tasmania
Country
Australia
Secondary sponsor category [1] 256378 0
University
Name [1] 256378 0
Monash University
Address [1] 256378 0
99 Commercial Rd, Melbourne 3004, Victoria
Country [1] 256378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259162 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [1] 259162 0
Ethics committee country [1] 259162 0
Australia
Date submitted for ethics approval [1] 259162 0
Approval date [1] 259162 0
23/03/2010
Ethics approval number [1] 259162 0
EC00337
Ethics committee name [2] 259163 0
Monash University Research Ethics Committee
Ethics committee address [2] 259163 0
Ethics committee country [2] 259163 0
Australia
Date submitted for ethics approval [2] 259163 0
Approval date [2] 259163 0
20/05/2010
Ethics approval number [2] 259163 0
EC00234

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31276 0
Address 31276 0
Country 31276 0
Phone 31276 0
Fax 31276 0
Email 31276 0
Contact person for public queries
Name 14523 0
A/Prof Changhai Ding
Address 14523 0
Menzies Research Institute, 17 Liverpool St, Hobart 7000, Tasmania;
Department of Epidemiology & Preventive Medicine, 99 Commercial Rd, Melbourne 3004, Victoria
Country 14523 0
Australia
Phone 14523 0
61-3-62267730
Fax 14523 0
61-3-62267704
Email 14523 0
[email protected]
Contact person for scientific queries
Name 5451 0
A/Prof Changhai Ding
Address 5451 0
Menzies Research Institute, 17 Liverpool St, Hobart 7000, Tasmania;
Department of Epidemiology & Preventive Medicine, 99 Commercial Rd, Melbourne 3004, Victoria
Country 5451 0
Australia
Phone 5451 0
61-3-62267730
Fax 5451 0
61-3-62267704
Email 5451 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCross-sectional and longitudinal associations between serum inflammatory cytokines and knee bone marrow lesions in patients with knee osteoarthritis.2017https://dx.doi.org/10.1016/j.joca.2016.10.024
EmbaseKnee effusion-synovitis volume measurement and effects of vitamin D supplementation in patients with knee osteoarthritis.2017https://dx.doi.org/10.1016/j.joca.2017.02.804
EmbaseVitamin D supplements for trunk muscle morphology in older adults: secondary analysis of a randomized controlled trial.2019https://dx.doi.org/10.1002/jcsm.12364
EmbaseAssociations between the morphological parameters of proximal tibiofibular joint (PTFJ) and changes in tibiofemoral joint structures in patients with knee osteoarthritis.2022https://dx.doi.org/10.1186/s13075-022-02719-8
N.B. These documents automatically identified may not have been verified by the study sponsor.