Boston Medical Center, Rheumatology Clinic
Boston, Massachusetts, 02118, United States
Location status: Recruiting
NCT Number: NCT06385275
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 (e.g., 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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02118, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One pill daily for 4 weeks.
Other names: Phylloquinone 500 µg
One pill daily for 4 weeks.
Other names: Phylloquinone 1000 µg
One pill daily for 4 weeks.
Other names: Menaquinone 300 µg
Placebo pill daily for 4 weeks.
Other names: Sugar pill
Time frame: Baseline, 4 weeks
Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Time frame: Baseline, 4 weeks
Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).
Time frame: Baseline, 4 weeks
Defined as the the proportion of participants achieving phylloquinone level of >1.0 nmol/L, which is the level achieved when adequate intakes are met.
Time frame: Baseline, 4 weeks
Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.
Time frame: 4 weeks
Adherence wil be assessed by analyzing pill counts for each participant.
Time frame: 4 weeks
Participants will use a 5 point LIkert scale to rate acceptability of the overall study, the pill tste, gastrointestinal tolerance, burden, and blood collection.
Contact information is provided by the study sponsor or research team.
Boston University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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