Vitamin D to Slow Progression of Knee Osteoarthritis - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Dietary Supplements (ODS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00306774

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.

If interested in participating in this study, please contact us at 617-636-5727 or arthritisresearch@tuftsmedicalcenter.org.

Condition	Intervention
Osteoarthritis, Knee	Dietary Supplement: Vitamin D (cholecalciferol) Dietary Supplement: Placebo

MedlinePlus related topics: Dietary Supplements Osteoarthritis

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Trial of Vitamin D to Reduce the Progression of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Once Daily Dosing Regimen

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive vitamin D (cholecalciferol)	Dietary Supplement: Vitamin D (cholecalciferol) 2,000 IU vitamin D capsule per day for 2 years
2: Placebo Comparator Participants will receive a matched placebo	Dietary Supplement: Placebo Placebo capusule 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

Criteria

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 posterioranterior (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306774

Locations

United States, Massachusetts
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Timothy E. McAlindon, MD, MPH

Tufts Medical Center

More Information

Responsible Party:	Tufts Medical Center ( Timothy E. McAlindon, MD, MPH - Prinipal Investigator )
Study ID Numbers:	R01 AR51361, R01 AR51361
Study First Received:	March 22, 2006
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00306774
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

osteoarthritis
vitamin D
knee pain
cartilage loss
WOMAC
MRI

cartilage volume
OA
physical function
web-based
internet-based

Study placed in the following topic categories:

Cholecalciferol
Osteoarthritis, Knee
Vitamin D
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Ergocalciferols
Disease Progression
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009