Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306774
Status:
COMPLETED
Last Update Posted:
2011-09-23
First Post:
2006-03-22
Brief Title:
Vitamin D to Slow Progression of Knee Osteoarthritis
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Trial of Vitamin D to Reduce the Progression of Knee Osteoarthritis A Double-Blind Placebo-Controlled Once Daily Dosing Regimen
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 2000 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
Patients with symptomatic knee OA will be randomly assigned to receive vitamin D at 2000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR051361 | NIH | None | httpsreporternihgovquickSearchR01AR051361 |