Clinical trial NCT05505552: Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:
Official title: Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: osteoarthritis
physical function
nutrition
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Tufts Medical Center
First posted: 2022-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Male or post-menopausal female (no menses in the last year)
* Plasma phylloquinone \<1.0 nmol/L
* 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?"
* Kellgren-Lawrence (KL) grade 2-3 in at least one knee
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability to answer questions by phone
* Ability to swallow capsules

Exclusion Criteria:

* KL grade 4 in at least one knee
* Inability to walk
* Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17)
* Widespread pain
* Malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, Crohn's disease, celiac sprue)
* Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation
* Plan to permanently relocate from the greater Boston, MA or Chapel Hill NC areas during the trial period
* Planned knee or hip arthroplasty during the study period
* Undergoing cancer treatment
* \< 50 years old
* Circulating phylloquinone ≥ 1.0 nmol/L
* Warfarin (Jantoven) use
* Use of other investigational drugs
* Use of herbal, botanical or vitamin K supplements
* Use of assistive walking devices

Primary outcomes:
measure: Plasma uncarboxylated matrix gla protein
timeFrame: 24 weeks
Secondary outcomes:
measure: Plasma phylloquinone
timeFrame: 24 weeks
Other outcomes:
measure: Lower-extremity function - self reported
timeFrame: 12 and 24 weeks
measure: Lower-extremity function - objective measures
timeFrame: 24 weeks
measure: Knee pain
timeFrame: 12 and 24 weeks
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
References: