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

NCT05505552 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-09-17

No results posted yet for this study

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.

As of February 2025, based on attrition rate below what was initially expected, we revised our planned enrollment from 50 to 35, to achieve the original goal of 30 completers. This was approved by the study sponsor.

Conditions

  • Osteo Arthritis Knee

Interventions

DIETARY_SUPPLEMENT

Vitamin K

1 mg/day phylloquinone (vitamin K1)

DIETARY_SUPPLEMENT

Placebo

Placebo capsule once daily

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Tufts Medical Center

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Tufts University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505552 on ClinicalTrials.gov