VItamin D Effect on Osteoarthritis Study

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 is to determine if vitamin D supplementation can reduce knee pain and slow knee cartilage loss in OA patients comparing with a placebo. Use of MRI will provide sensitive measures of knee OA changes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies Institute for Medical Research
• Collaborator: Monash University
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Age 50-79 years old;

2. 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;

3. Have an American College of Rheumatology (ACR) functional class rating of I, II and III;

4. 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]);

5. Have serum vitamin D level of >12.5 nmol/L and <60 nmol/L;

6. Are able to read, speak and understand English, capable of understanding the study requirements and willing to co-operate with the study instructions;

7. Are able and willing to give informed consent;

8. Are willing and able to give blood samples;

9. Are willing and able to have knee MRIs performed

Exclusion Criteria:

1. Have Grade 3 radiographic changes in their knee which is to be investigated;

2. Have severe knee pain (more than 80 mm on a 100-mm visual analogue scale,VAS) in most days of the last month;

3. Have any contra-indications for having MRIs scans performed;

4. 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;

5. Have ever had knee joint replacement;

6. Have anticipated need for knee or hip surgery in the next 2 years;

7. Have any stomach or intestinal condition possibly affecting oral drug absorption;

8. 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.