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NCT05505552 · ClinicalTrials.gov registry record · NA
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:
A NA study of Osteoarthritis, Knee, sponsored by Tufts University.
- Active
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 3
- Study locations
NCT05505552: Active NA study of Osteoarthritis, Knee, sponsored by Tufts University.
NCT05505552 is a NA study of Osteoarthritis, Knee that is active but no longer recruiting, run by Tufts University. The registered enrollment target is 37 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05505552, a NA study of Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Tufts University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Vitamin K
Study Locations (3)
Massachusetts
- Tufts University - Boston
- UMass Memorial Medical Center - Worcester
North Carolina
- University of North Carolina Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-09-20 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What the registry record for NCT05505552 still lists
NCT05505552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05505552 reports a single indexed study location in Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05505552 about?
NCT05505552 is a clinical study titled "Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:". 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 desig...
What is the current status of trial NCT05505552?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 37 participants. The study started on 2023-09-20. Estimated completion is 2026-12-31.
What conditions does trial NCT05505552 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT05505552?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Vitamin K (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05505552?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05505552 being conducted?
This trial has 3 study locations across Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05505552's enrollment target sits among peer trials
37 96th of 112 higher than 17 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mobilizing Hispanics With Knee Osteoarthritis
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-
The Osteoarthritis Prevention Study
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-
Navio Robotic Versus Conventional Total Knee Arthroplasty
RECRUITING · NA
-
MOTION Clinical Trial
RECRUITING · NA
-
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
RECRUITING · NA
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