Vitamin D to Slow Progression of Knee Osteoarthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

Knee osteoarthritis (OA) is a common and disabling health problem in older adults and for which there is no cure. The purpose of this study is to determine the effects of vitamin D on knee OA symptoms and physical function in adults aged 45 years and older.

Key facts

Study ID

NCT00306774

Run by

Tufts Medical Center

People needed

146

Starts

2006-03-01

Expected to finish

2009-06-01

Last updated by the study team

2011-09-23

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?"
• WOMAC pain subscale score of at least 1
• Tibiofemoral OA on posterior anterior (PA) weight-bearing semi-flexed knee radiographs with severity equivalent to Kellgren and Lawrence grade of at least 2
• Clinical examination confirming knee pain or discomfort referable to the knee joint
• Prepared to refrain from use of glucosamine, chondroitin, MSM, DMSO, and doxycycline
• Pass faintness of heart trial period

You may not qualify if…

• Serum 25(OH) vitamin D level greater than 80 ng/ml
• Use of glucosamine, chondroitin, or doxycycline within 3 months of random assignment
• Use of MSM, DMSO within 3 months of random assignment
• Use of vitamin D supplements such that the total daily dose is greater than 1,000 IU or a single source is greater than 800 IU
• Intra-articular joint injections (e.g., glucocorticoid or haluronic acid formulations, within 3 months of random assignment)
• Chronic glucocorticoid use
• Hypercalcemia (total serum calcium greater than 10.5 mg/dL)
• Hypercalcuria (spot urine calcium: creatinine ratio of 0.275 for women and 0.325 for men, corresponding to 24-hour calcium excretion of 0.30 and 0.35 g, respectively)
• Estimated GFR less than 30
• Hyperparathyroidism (PTH greater than 65 pg/mL)
• History of lymphoma or sarcoidosis
• Reiter's syndrome
• Psoriatic arthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Currently on treatment for tuberculosis
• Malabsorption disorders (e.g., advance liver disease, chronic renal disease-stage 4 or 5, Crohn's disease, Whipple's disease, celiac sprue)
• Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation
• Pregnancy
• 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 scan

Where it is running

• Tufts Medical Center, Division of Rheumatology — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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