Does vitamin D supplementation prevent progression of knee osteoarthritis? A randomised controlled trial

Phase 3

• Conditions: Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12610000495022
• Lead Sponsor: Menzies Research Institute, University of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oss of knee cartilage volume, as assessed by magnetic resonance imaging (MRI).[MRI assessment will occur at month 0 (baseline) and 24.]

Secondary Outcome Measures

Name	Time	Method
The progression of knee cartilage defects and enlargement of tibial bone area, as assessed by MRI;[MRI assessment will occur at month 0 (baseline) and 24.];Loss of lower limb muscle strength, measured by dynamometry;[Muscle strength assessment will occur at month 0, 3, 6, 12 and 24.];Progress of knee pain, assessed by The Western Ontario & McMaster Universities Arthritis Index (WOMAC).[Knee pain assessment will occur at month 0, 3, 6, 12 and 24.]