Effect of vitamin D supplementation on progression of osteoarthritis knee

Phase 4

Conditions: Health Condition 1: null- Osteoarthritis knee

Registration Number: CTRI/2014/06/004658

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Cartilage volume loss- At screening & 24 months <br/ ><br>â?¢Alignment and status of Osteophytes- At screening & 24 months <br/ ><br>â?¢Knee symptoms- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢Knee pain- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>Timepoint: â?¢ At screening & 24 months <br/ ><br>â?¢ At screening & 24 months <br/ ><br>â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
â?¢Physical function- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢Quality of life- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢Pathological severity global score- At screening & 24 months <br/ ><br>Timepoint: â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months <br/ ><br>â?¢At screening & 24 months <br/ ><br>