None listed
Conditions
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.
Interventions
Participants in the intervention arm will receive 50,000 IU (1.25 mg) cholecalciferol (vitamin D3) tablets given once monthly for 2 years
Sponsors
Menzies Research Institute, University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to 79 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed