Effects of vitamin D supplementation on knee pain, knee structural change, and lower limb muscle strength in patients with symptomatic knee osteoarthritis: A randomised, double-blind, placebo-controlled trial

Menzies Research Institute, University of Tasmania0 个研究点目标入组 400 人开始时间: 2010年6月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Menzies Research Institute, University of Tasmania