A randomised, double-blind, placebo-controlled trial of Vitamin D supplementation in the management of symptomatic knee osteoarthritis (the VIDEO study)
| ISRCTN | ISRCTN94818153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94818153 |
| Secondary identifying numbers | 15622 |
- Submission date
- 05/04/2005
- Registration date
- 03/05/2005
- Last edited
- 20/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=43
Contact information
Dr Richard Keen
Scientific
Scientific
Metabolic Unit
Royal National Orthopaedic Hospital Stanmore
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, double-blind, placebo-controlled trial of Vitamin D supplementation in the management of symptomatic knee osteoarthritis (the VIDEO study) |
| Study acronym | VIDEO (VItamin D Evaluation in Osteoarthritis) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2004 |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 800 (478 achieved as of 08/08) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 31/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Metabolic Unit
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Sponsor information
Royal National Orthopaedic Hospital (UK)
Not defined
Not defined
RNOH Stanmore
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
"ROR" |
https://ror.org/043j9bc42 |
|---|
Funders
Funder type
Charity
Arthritis Research Campaign 15622
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| Results article | sub study results | 01/09/2017 | Yes | No |
Editorial Notes
20/03/2017: Publication reference added.
