Condition category
Musculoskeletal Diseases
Date applied
05/04/2005
Date assigned
03/05/2005
Last edited
11/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Richard Keen

ORCID ID

Contact details

Metabolic Unit
Royal National Orthopaedic Hospital Stanmore
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15622

Study information

Scientific title

Acronym

VIDEO (VItamin D Evaluation in Osteoarthritis)

Study hypothesis

Vitamin D supplementation may reduce the rate of disease progression and improve symptoms in participants with knee osteoarthritis.

On 29/03/2011 the anticipated end date was changed from 31/01/2009 to 31/08/2011.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

Participants will be randomised to receive oral vitamin D (as cholecalciferol) 800 IU/day (20 µg/day) or matching placebo tablets.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measures

Radiological progression of knee OA in medial joint compartment at 36 months

Secondary outcome measures

1. Radiological progression of knee OA in other joint compartments
2. Reduction in pain and functional disability
3. Improvement in quality of life

Overall trial start date

01/02/2004

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants aged over 50
2. Male or female
3. Ambulatory (not wheelchair bound)
4. Able and willing to attend or comply with treatment and follow-up
5. Radiological evidence of early disease at medial tibio-femoral knee compartment (modified Kellgren & Lawrence [k&l] score 2/3, joint space width [JSW] >1 mm)
6. Pain in knee for most days of previous month
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800 (478 achieved as of 08/08)

Participant exclusion criteria

1. Secondary osteoarthritis (OA), septic arthritis, gout, Wilson's disease, Paget's disease, pseudo gout
2. History of inflammatory arthritis
3. Knee stiffness >30 minutes duration
4. Current user of cod liver oil or vitamin D supplementation
5. Current use of glucosamine or chondroitin for less than 3 months
6. History of hyperparathyroidism or osteomalacia
7. Current use of anti-epileptic medication
8. Current use of bisphosphonates or use within 2 years
9. History of hypercalcaemia or hypercalciuria
10. History of hyperthyroidism, sarcoidosis
11. History of renal stones
12. Previous intra-articular injection: steroid within 3 months, hyalgan within 6 months
13. Previous knee surgery or arthroscopy within 6 months
14. History of osteoporotic fracture
15. History of cancer within last 5 years, excluding skin cancer
16. Serious psychiatric disorders including dementia
17. Inability to understand the procedures
18. Inability to attend or comply with treatment or follow-up scheduling
19. Pregnancy

Recruitment start date

01/02/2004

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Metabolic Unit
Stanmore
HA7 4LP
United Kingdom

Sponsor information

Organisation

Royal National Orthopaedic Hospital (UK)

Sponsor details

RNOH Stanmore
Brockley Hill
Stanmore
HA7 4LP
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign 15622

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes