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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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma uncarboxylated matrix gla protein
Secondary study objectives
Plasma phylloquinone
Other study objectives
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%
Depression
7%
Pain in extremity
7%
Hypoaesthesia
7%
Insomnia
7%
Diarrhoea
7%
Alanine aminotransferase increased
6%
Influenza
6%
Lymphadenopathy
5%
Oral herpes
5%
Spinal pain
5%
Migraine
5%
Muscle spasticity
5%
Muscle spasms
5%
Hypothyroidism
2%
Pneumonia
2%
Postmenopausal haemorrhage
1%
Neutropenia
1%
Autoimmune hepatitis
1%
Sarcoidosis
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
270 Previous Clinical Trials
594,841 Total Patients Enrolled
2 Trials studying Osteoarthritis
289 Patients Enrolled for Osteoarthritis
University of North Carolina, Chapel HillOTHER
1,557 Previous Clinical Trials
4,299,002 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,824 Patients Enrolled for Osteoarthritis
Tufts Medical CenterOTHER
263 Previous Clinical Trials
264,288 Total Patients Enrolled
9 Trials studying Osteoarthritis
1,193 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.
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