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

Primary Purpose

Osteo Arthritis Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin K
Placebo
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteo Arthritis Knee focused on measuring osteoarthritis, physical function, nutrition

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts University
  • University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin K

Placebo

Arm Description

Participants receive 1 mg/d phylloquinone orally for 24 weeks

Participants receive daily placebo matching phylloquinone for 24 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 15, 2022
Last Updated
April 10, 2023
Sponsor
Tufts University
Collaborators
University of North Carolina, Chapel Hill, Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05505552
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
University of North Carolina, Chapel Hill, Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
osteoarthritis, physical function, nutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin K
Arm Type
Experimental
Arm Description
Participants receive 1 mg/d phylloquinone orally for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive daily placebo matching phylloquinone for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K
Other Intervention Name(s)
Phylloquinone
Intervention Description
1 mg/day phylloquinone (vitamin K1)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule once daily
Primary Outcome Measure Information:
Title
Plasma uncarboxylated matrix gla protein
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Plasma phylloquinone
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Lower-extremity function - self reported
Description
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.
Time Frame
12 and 24 weeks
Title
Lower-extremity function - objective measures
Description
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.
Time Frame
24 weeks
Title
Knee pain
Description
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.
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Booth, PhD
Phone
617 556 3231
Email
sarah.booth@tufts.edu
Facility Information:
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Booth, PhD
Phone
617-556-3231
Email
sarah.booth@tufts.edu
First Name & Middle Initial & Last Name & Degree
Kyla Shea, PhD
Phone
617 556 3370
Email
kyla.shea@tufts.edu
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Loeser, MD
Email
richard_loeser@med.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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