Health Condition 1: null- Osteoarthritis knee
Conditions
Interventions
Intervention1: Vitamin D (Cholecalciferol): 60,000 IU OD orally for 10 days continuously, then 60,000 IU once in a month for 2 years
Control Intervention1: Placebo: Placebo OD orally for 10 days conti
Sponsors
Indian Council of Medical Research
Dr S M Natu Professor
Eligibility
Inclusion criteria
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 ( • 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Cartilage volume loss- At screening & 24 months â?¢ Alignment and status of Osteophytes- At screening & 24 months â?¢ Knee symptoms- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢ Knee pain- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months Timepoint: â?¢ At screening & 24 months â?¢ At screening & 24 months â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Physical function- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢ Quality of life- At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢ Pathological severity global score- At screening & 24 months Timepoint: â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢ At screening, 3, 6, 9, 12, 15, 18, 21, 24 months â?¢At screening & 24 months | — |
Countries
India
Contacts
Public ContactSudeepti R Srivastava
King Georgeâ??s Medical University
Outcome results
None listed