Effect of vitamin D on progression of primary osteoarthritis knee- A double blind randomized control trial

Indian Council of Medical Research0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Patient of either sex diagnosed as OA knee as per ACR guidelines:
•(A) Knee pain with osteophytes on X- ray.
•(B) One of the following: a) Crepitus on knee range of motion
•b) Age 40 years or older
•c) Morning stiffness of short duration ( <30 minutes)
•Chronic knee discomfort.
•WOMAC pain subscale score of at least 1.
•Tibio- femoral OA on posterior anterior weight bearing semi- flexed knee radiographs with severity equivalent to Kellgren and Lawrence grade of at least 2.
•Prepared to refrain from use of glucosamine, chondroitin, MSM, DMSO and doxycyclin.

•Secondary osteoarthritis.
•Serum 25 (OH) vitamin D level greater than 50nmol/L.
•Hypercalcemia (total serum calcium greater than 10.5 mg/dL).
•Hypercalcuria (spot urine calcium: creatinine ratio of 0.275 for women & 0.325 for men, corresponding to 24 hour calcium excretion of 0.30 and 0.35 g respectively).
•Hyperparathyroidism (PTH greater than 65 pg/ml).
•Malabsorption disorders (e.g., advance liver disease, chronic renal disease, Crohnâ??s disease, Whippleâ??s disease, Celiac disease).
•Pregnancy.
•Use of glucosamine, chondroitin or doxycycline within 3 months of random assignment.
•Use of MSM, DMSO within 3 months of random assignment.
•Intra- articular joint infections.
•Chronic glucocorticoid use.
•History of lymphoma or sarcoidosis.
•Currently on treatment for tuberculosis.
•Serious medical conditions or impairments that, in view of the investigator, would obstruct study participation.
•Plan to permanently relocate from the region during the trial period.
•Planned knee or hip arthroplasty during the study period.
•Any contra- indication to having an MRI scans.

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