ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Drugs

Intervention code [2]

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]

Loss of knee cartilage volume, as assessed by magnetic resonance imaging (MRI).

Timepoint [1]

MRI assessment will occur at month 0 (baseline) and 24.

Secondary outcome [1]

The progression of knee cartilage defects and enlargement of tibial bone area, as assessed by MRI;

Timepoint [1]

MRI assessment will occur at month 0 (baseline) and 24.

Secondary outcome [2]

Loss of lower limb muscle strength, measured by dynamometry;

Timepoint [2]

Muscle strength assessment will occur at month 0, 3, 6, 12 and 24.

Secondary outcome [3]

Progress of knee pain, assessed by The Western Ontario & McMaster Universities Arthritis Index (WOMAC).

Timepoint [3]

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?

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]

Government body

Name [1]

National Health & Medical Research Council (NHMRC)

Address [1]

Level 1 16 Marcus Clarke Street Canberra ACT 2601

Country [1]

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]

University

Name [1]

Monash University

Address [1]

99 Commercial Rd, Melbourne 3004, Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health & Medical Human Research Ethics Committee

Ethics committee address [1]

Research House, Sandy Bay Campus, Private Bag 01, Hobart 7001, Tasmania

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/03/2010

Ethics approval number [1]

EC00337

Ethics committee name [2]

Monash University Research Ethics Committee

Ethics committee address [2]

Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton 3800, Victoria

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

20/05/2010

Ethics approval number [2]

EC00234

Summary

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

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

A/Prof Changhai Ding

Address

Menzies Research Institute, 17 Liverpool St, Hobart 7000, Tasmania;
Department of Epidemiology & Preventive Medicine, 99 Commercial Rd, Melbourne 3004, Victoria

Country

Australia

Phone

61-3-62267730

Fax

61-3-62267704

chding@utas.edu.au

Contact person for scientific queries

Name

A/Prof Changhai Ding

Address

Menzies Research Institute, 17 Liverpool St, Hobart 7000, Tasmania;
Department of Epidemiology & Preventive Medicine, 99 Commercial Rd, Melbourne 3004, Victoria

Country

Australia

Phone

61-3-62267730

Fax

61-3-62267704

chding@utas.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Cross-sectional and longitudinal associations between serum inflammatory cytokines and knee bone marrow lesions in patients with knee osteoarthritis.	2017	https://dx.doi.org/10.1016/j.joca.2016.10.024
Embase	Knee effusion-synovitis volume measurement and effects of vitamin D supplementation in patients with knee osteoarthritis.	2017	https://dx.doi.org/10.1016/j.joca.2017.02.804
Embase	Vitamin D supplements for trunk muscle morphology in older adults: secondary analysis of a randomized controlled trial.	2019	https://dx.doi.org/10.1002/jcsm.12364
Embase	Associations between the morphological parameters of proximal tibiofibular joint (PTFJ) and changes in tibiofemoral joint structures in patients with knee osteoarthritis.	2022	https://dx.doi.org/10.1186/s13075-022-02719-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically