Vitamin D to Slow Progression of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

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 and physical function in adults aged 45 years and older.
    

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.
    

Intervention name(s): Vitamin D (cholecalciferol); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2,000 IU vitamin D capsule per day for 2 years; Placebo capsule per day for 2 years
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; vitamin D; knee pain; cartilage loss; WOMAC; MRI; cartilage volume; OA; physical function; web-based; internet-based