Vitamin K for Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tufts University, Boston, MA
Knee+2 More
Vitamin K - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Knee

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 and 24 weeks

12 and 24 weeks
Knee pain
Lower-extremity function - self reported
24 weeks
Lower-extremity function - objective measures
Plasma phylloquinone
Plasma uncarboxylated matrix gla protein

Trial Safety

Safety Progress

1 of 3

Other trials for Knee

Side Effects for

DAC HYP 150 mg
44%Multiple sclerosis relapse
25%Upper respiratory tract infection
23%Urinary tract infection
16%Headache
14%Nasopharyngitis
11%Pharyngitis
11%Back pain
10%Influenza like illness
9%Pyrexia
9%Fatigue
8%Arthralgia
8%Anxiety
8%Muscular weakness
8%Sinusitis
7%Diarrhoea
7%Depression
7%Alanine aminotransferase increased
7%Hypoaesthesia
7%Pain in extremity
7%Insomnia
6%Influenza
6%Lymphadenopathy
5%Oral herpes
5%Hypothyroidism
5%Muscle spasms
5%Migraine
5%Muscle spasticity
5%Spinal pain
2%Postmenopausal haemorrhage
2%Pneumonia
1%Hydronephrosis
1%Suicide attempt
1%Obesity
1%Cutaneous sarcoidosis
1%Infection
1%Lumbar spinal stenosis
1%Neutropenia
1%Autoimmune hepatitis
1%Hepatic enzyme increased
1%Endometrial hypertrophy
1%Endometriosis
1%Abortion missed
1%Hepatitis E
1%Ovarian cyst
1%Sarcoidosis
1%Haemolytic anaemia
1%Furuncle
1%Streptococcal urinary tract infection
1%Toxicity to various agents
1%Erythema nodosum
1%Rash
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT01462318) in the DAC HYP 150 mg ARM group. Side effects include: Multiple sclerosis relapse with 44%, Upper respiratory tract infection with 25%, Urinary tract infection with 23%, Headache with 16%, Nasopharyngitis with 14%.

Trial Design

2 Treatment Groups

Vitamin K
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Vitamin K · Has Placebo Group · N/A

Vitamin K
DietarySupplement
Experimental Group · 1 Intervention: Vitamin K · Intervention Types: DietarySupplement
Placebo
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin K
2016
Completed Phase 3
~410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 and 24 weeks
Closest Location: Tufts University · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2007First Recorded Clinical Trial
0 TrialsResearching Knee
31 CompletedClinical Trials

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,347 Previous Clinical Trials
3,908,538 Total Patients Enrolled
Tufts Medical CenterOTHER
228 Previous Clinical Trials
238,545 Total Patients Enrolled
Tufts UniversityLead Sponsor
235 Previous Clinical Trials
557,678 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.