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 |
| Protocol serial number | 15622 |
| Sponsor | Royal National Orthopaedic Hospital (UK) |
| Funder | Arthritis Research Campaign 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Radiological progression of knee OA in medial joint compartment at 36 months |
| Key secondary outcome measure(s) |
1. Radiological progression of knee OA in other joint compartments |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 800 |
| 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
- United Kingdom
- England
Study participating centre
Metabolic Unit
Stanmore
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/03/2017: Publication reference added.
