Status:
COMPLETED
VItamin D Effect on Osteoarthritis Study
Lead Sponsor:
Menzies Institute for Medical Research
Collaborating Sponsors:
Monash University
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50-79 years
Phase:
PHASE3
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 ev...
Detailed Description
Osteoarthritis (OA) is the most common joint disorder in the world. In 2004, OA was estimated to affect over 1.6 million Australians, with total costs of $1.4 billion. OA is the most frequent reason f...
Eligibility Criteria
Inclusion
- Age 50-79 years old;
- Men and women with symptomatic knee osteoarthritis (OA) with a pain visual analogue scale (VAS) of at least 20 mm in most days of the last month;
- Have an American College of Rheumatology (ACR) functional class rating of I, II and III;
- 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 \[very poor\]);
- Have serum vitamin D level of \>12.5 nmol/L and \<60 nmol/L;
- Are able to read, speak and understand English, capable of understanding the study requirements and willing to co-operate with the study instructions;
- Are able and willing to give informed consent;
- Are willing and able to give blood samples;
- Are willing and able to have knee MRIs performed
Exclusion
- Have Grade 3 radiographic changes in their knee which is to be investigated;
- Have severe knee pain (more than 80 mm on a 100-mm visual analogue scale,VAS) in most days of the last month;
- Have any contra-indications for having MRIs scans performed;
- Have had significant trauma to the knees including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the screening visit;
- Have ever had knee joint replacement;
- Have anticipated need for knee or hip surgery in the next 2 years;
- Have any stomach or intestinal condition possibly affecting oral drug absorption;
- Have any clinically significant condition(s) such as (but not limited to) rheumatoid arthritis, psoriatic arthritis, lupus, active cancer, cardiac or renal function impairment or hypersensitivity to vitamin D that in the opinion of the investigator may compromise their safety or compliance, interfere with evaluation or preclude completion of the study.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT01176344
Start Date
August 1 2010
End Date
December 1 2014
Last Update
September 9 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Menzies Research Institute, University of Tasmania
Hobart, Tasmania, Australia, 7000
2
Department of Epidemiology & Preventive Medicine, Monash University
Melbourne, Victoria, Australia, 3004