protocolSection identificationModule nctId: NCT06385275, orgStudyIdInfo id: H-44897, briefTitle: The Role of Vitamin K on Knee Osteoarthritis Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Boston University, class: OTHER, collaborators name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), descriptionModule briefSummary: 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; 360µg 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., conditionsModule conditions: Osteo Arthritis Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin K1 500 µg, interventions name: K1 1000 µg, interventions name: Vitamin K2 (MK-7) 360 µg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in uncarboxylated matrix Gla protein (ucMGP) levels, primaryOutcomes measure: Change in phylloquinone levels, primaryOutcomes measure: Sufficient phylloquinone levels, primaryOutcomes measure: Change in menaquinone-7 (MK-7) levels, secondaryOutcomes measure: Study adherence, secondaryOutcomes measure: Participant acceptability of intervention, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston Medical Center, Rheumatology Clinic, city: Boston, state: Massachusetts, zip: 02118, country: United States, contacts name: Jean Liew, MD MS, role: CONTACT, phone: 617-358-9655, email: jwliew@bu.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False