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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
Study Summary
This trial is testing whether or not vitamin K supplementation affects knee osteoarthritis progression and related functional decline in adults with mild to moderate knee OA.
Who is the study for?
Adults over 50 with mild to moderate knee osteoarthritis and low vitamin K levels can join this study. Participants must be able to swallow capsules, have no severe cognitive impairments or serious medical conditions that would interfere with the trial, not use walking aids or certain supplements, and not plan major relocations or surgeries during the study.Check my eligibility
What is being tested?
The trial is testing if taking 1 mg of Vitamin K daily for six months can slow down knee osteoarthritis progression compared to a placebo. It's a double-blind study where neither participants nor researchers know who gets Vitamin K or placebo until after the results are collected.See study design
What are the potential side effects?
Vitamin K is generally considered safe but could cause an upset stomach, taste changes, or allergic reactions in some people. The placebo should have no active effects but might cause similar symptoms due to psychological factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma uncarboxylated matrix gla protein
Secondary outcome measures
Plasma phylloquinone
Other outcome measures
Knee pain
Lower-extremity function - objective measures
Lower-extremity function - self reported
Side effects data
From 2016 Phase 3 trial • 133 Patients • NCT0146231844%
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%
Fatigue
9%
Pyrexia
8%
Muscular weakness
8%
Sinusitis
8%
Arthralgia
8%
Anxiety
7%
Hypoaesthesia
7%
Depression
7%
Pain in extremity
7%
Insomnia
7%
Diarrhoea
7%
Alanine aminotransferase increased
6%
Influenza
6%
Lymphadenopathy
5%
Oral herpes
5%
Muscle spasms
5%
Spinal pain
5%
Migraine
5%
Muscle spasticity
5%
Hypothyroidism
2%
Pneumonia
2%
Postmenopausal haemorrhage
1%
Sarcoidosis
1%
Autoimmune hepatitis
1%
Neutropenia
1%
Streptococcal urinary tract infection
1%
Toxicity to various agents
1%
Obesity
1%
Lumbar spinal stenosis
1%
Furuncle
1%
Hepatitis E
1%
Hepatic enzyme increased
1%
Infection
1%
Haemolytic anaemia
1%
Suicide attempt
1%
Abortion missed
1%
Hydronephrosis
1%
Endometrial hypertrophy
1%
Endometriosis
1%
Ovarian cyst
1%
Cutaneous sarcoidosis
1%
Erythema nodosum
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
DAC HYP 150 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin KExperimental Treatment1 Intervention
Participants receive 1 mg/d phylloquinone orally for 24 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants receive daily placebo matching phylloquinone for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin K
2016
Completed Phase 4
~570
Find a Location
Who is running the clinical trial?
Tufts UniversityLead Sponsor
265 Previous Clinical Trials
661,824 Total Patients Enrolled
2 Trials studying Osteoarthritis
289 Patients Enrolled for Osteoarthritis
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,190,564 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,875 Patients Enrolled for Osteoarthritis
Tufts Medical CenterOTHER
255 Previous Clinical Trials
255,218 Total Patients Enrolled
8 Trials studying Osteoarthritis
691 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can answer questions over the phone.I am scheduled for knee or hip replacement surgery.I am under 50 years old.I have moderate knee arthritis.I experience pain in many parts of my body.I am taking Warfarin.I am a man or a woman who has not had a menstrual cycle in the last year.I am currently receiving treatment for cancer.I am unable to walk.I have had knee pain, aching, or stiffness for most days in the past year.I can swallow pills.I use devices like canes or walkers to help me move around.I am 50 years old or older.I use herbal, botanical, or vitamin K supplements.I do not have severe liver, kidney disease, Crohn's, or celiac disease.I understand and can follow the study's procedures.I have had knee pain, aching, or stiffness for most days in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin K
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for volunteers to join this clinical trial?
"According to clinicaltrials.gov, this medical experiment is not presently enrolling patients. The trial was initially publicized on January 1st 2023 and last updated October 30th 2022. Despite the fact that it's currently inactive, there are an abundance of 693 other ongoing trials seeking volunteers right now."
Answered by AI
Who else is applying?
What state do they live in?
California
North Carolina
Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
3+
What site did they apply to?
Tufts University
University of North Carolina Chapel Hill
Why did patients apply to this trial?
I could have had knee surgery on both knees when diagnosed approx 4 years ago.
PatientReceived 1 prior treatment
I’m always looking to help studies with trials that will better help us now, and in the future.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long do the visits take?
PatientReceived 2+ prior treatments
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