Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:

Osteo Arthritis Knee Clinical Trial

Official title:

Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505552
• Other study ID #: R21AR080297
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Tufts University
• Contact: Sarah Booth, PhD
• Phone: 617 556 3231
• Email: sarah.booth[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Vitamin K
1 mg/day phylloquinone (vitamin K1)
• Placebo
Placebo capsule once daily

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Tufts Medical Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lower-extremity function - self reported	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function index is a disease-specific, self-administered questionnaire, for assessing health status and health outcomes in osteoarthritis of the knee and/or hip. WOMAC function scores range from 0-68, with lower scores reflecting better function.	12 and 24 weeks
Other	Lower-extremity function - objective measures	40-m fast gait speed, Chair stand test, Stair climb test, Timed-up-and-go test, 6 min walk test are measures of lower-extremity function recommended by the Osteoarthritis Research Society International to test physical performance in people with knee OA.	24 weeks
Other	Knee pain	Knee pain, which is symptomatic of OA, will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Measurement of Intermittent and Constant Osteoarthritis Pain (ICOAP) self-reported questionnaires. WOMAC pain scores range from 0-20, with higher scores reflecting more pain. ICOAP scores range from 0-100, with higher scores reflecting more pain.	12 and 24 weeks
Primary	Plasma uncarboxylated matrix gla protein	Plasma uncarboxylated matrix gla protein is considered a functional indicator of vitamin K status. We will evaluate how it changes in response to 1 mg/d vitamin K supplementation in adults with low vitamin K status at baseline and with radiographic knee OA.	24 weeks
Secondary	Plasma phylloquinone	Circulating phylloquinone is considered a global indicator of vitamin K status. We will evaluate how it changes in response to 1 mg/d vitamin K supplementation in adults with low vitamin K status at baseline and with radiographic knee OA.	24 weeks