Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385275
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-21
Brief Title:
The Role of Vitamin K on Knee Osteoarthritis Outcomes
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
The Role of Vitamin K on Knee Osteoarthritis Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis OA are not known In intervention studies for conditions other than knee OA eg prevention of cardiovascular disease the most commonly used forms and doses include phylloquinone vitamin K1 1000µg or 500µg daily or menaquinone-7 MK-7 or vitamin K2 300µg daily However whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known Furthermore although some studies suggest enhanced bioavailability of MK-7 over vitamin K1 as well as extra-hepatic effects whether this is relevant for an older population with knee OA is not known
The overall goal of this pilot randomized clinical trial RCT is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures
The overall goal of this pilot randomized clinical trial RCT is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None