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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
Comparator / control treatment
The control arm will receive an identical inert placebo (1.25 mg microcrystalline cellulose tablet).
Control group

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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)
Address [1] 257116 0
Level 1 16 Marcus Clarke Street Canberra ACT 2601
Country [1] 257116 0
Primary sponsor type
Menzies Research Institute, University of Tasmania
17 Liverpool St, Hobart 7000, Tasmania
Secondary sponsor category [1] 256378 0
Name [1] 256378 0
Monash University
Address [1] 256378 0
99 Commercial Rd, Melbourne 3004, Victoria
Country [1] 256378 0

Ethics approval
Ethics application status
Ethics committee name [1] 259162 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [1] 259162 0
Research House, Sandy Bay Campus, Private Bag 01, Hobart 7001, Tasmania
Ethics committee country [1] 259162 0
Date submitted for ethics approval [1] 259162 0
Approval date [1] 259162 0
Ethics approval number [1] 259162 0
Ethics committee name [2] 259163 0
Monash University Research Ethics Committee
Ethics committee address [2] 259163 0
Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton 3800, Victoria
Ethics committee country [2] 259163 0
Date submitted for ethics approval [2] 259163 0
Approval date [2] 259163 0
Ethics approval number [2] 259163 0

Brief summary
Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. This study will compare knee OA structural changes in patients receiving vitamin D supplementation with those receiving a placebo. Use of MRI will provide sensitive measures of knee OA changes.
Trial website
Trial related presentations / publications
Public notes

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
Phone 14523 0
Fax 14523 0
Email 14523 0
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
Phone 5451 0
Fax 5451 0
Email 5451 0

No information has been provided regarding IPD availability
Summary results
No Results