Status:
COMPLETED
Vitamin D to Slow Progression of Knee Osteoarthritis
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45-90 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Symptomatic knee OA is one of the most frequent causes of limitation in lower limb tasks, especially in the elderly. Knee OA causes 68 million lost work days per year. OA is the most frequent reason f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00306774
Start Date
March 1 2006
End Date
June 1 2009
Last Update
September 23 2011
Active Locations (1)
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1
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, United States, 02111