Vitamin D to Slow Progression of Knee Osteoarthritis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Dietary Supplement: Vitamin D (cholecalciferol) Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Trial of Vitamin D to Reduce the Progression of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Once Daily Dosing Regimen |
- Cartilage volume loss (MRI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Knee symptoms (WOMAC questionnaire) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Physical function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Pathological (MRI) severity global score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 146 |
| Study Start Date: | March 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive vitamin D (cholecalciferol)
|
Dietary Supplement: Vitamin D (cholecalciferol)
2,000 IU vitamin D capsule per day for 2 years
|
|
Placebo Comparator: 2
Participants will receive a matched placebo
|
Dietary Supplement: Placebo
Placebo capsule per day for 2 years
|
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 for joint replacement, at a cost of billions of dollars per year. There are currently no completely effective medical remedies for OA. Pharmaceutical companies are trying to develop drugs that will slow the disease progression of OA; however, such medications will be expensive to use in a population in which OA is common. There is evidence that vitamin D supplementation, a simple and much cheaper intervention, may prove useful in slowing the progression of OA. Even if only modestly effective, it could have considerable impact in terms of reducing the societal burden of OA. Therefore, in the interests of public health, the efficacy of vitamin D supplementation as a disease-modifying treatment for OA needs to be tested in a rigorous clinical trial. Disease modification trials for knee OA have been difficult in the past due to limitations of radiographic techniques. Fortunately, magnetic resonance imaging (MRI) has emerged as a valid, precise, and reproducible tool for the measurement of damage of cartilage and joint structures. The purpose of this study is to evaluate the effects of vitamin D on knee OA symptoms and physical function in older adults.
Patients with symptomatic knee OA will be randomly assigned to receive vitamin D at 2,000 International Units (IU) a day or placebo. Each participant will be in the study for about 2 years. During that time, there will be 9 scheduled study visits (screening, Months 0, 2, 4, 8, 12, 16, 20, and 24) and interim safety visits as needed. Measurements of vital signs, a knee exam, blood and urine collection, pill counts, and completion of questionnaires will occur at all visits. Participants' physical function will be assessed at study entry and Months 0, 12, and 24. MRI, bone density scanning, and an assessment by the study staff will occur at Months 0, 12, and 24. Knee x-rays will occur at study screening and Month 24.
Eligibility| Ages Eligible for Study: | 45 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| United States, Massachusetts | |
| Tufts Medical Center, Division of Rheumatology | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Timothy E. McAlindon, MD, MPH | Tufts Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00306774 History of Changes |
| Other Study ID Numbers: | R01 AR051361, R01AR051361, R01 AR51361 |
| Study First Received: | March 22, 2006 |
| Last Updated: | September 21, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Tufts Medical Center:
|
osteoarthritis vitamin D knee pain cartilage loss WOMAC MRI |
cartilage volume OA physical function web-based internet-based |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013