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Vitamin K for Osteoarthritis

N/A
Recruiting
Research Sponsored by Tufts University
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

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 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

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 • NCT01462318
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%
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
596,479 Total Patients Enrolled
2 Trials studying Osteoarthritis
289 Patients Enrolled for Osteoarthritis
University of North Carolina, Chapel HillOTHER
1,554 Previous Clinical Trials
4,293,083 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,824 Patients Enrolled for Osteoarthritis
Tufts Medical CenterOTHER
263 Previous Clinical Trials
264,411 Total Patients Enrolled
9 Trials studying Osteoarthritis
1,193 Patients Enrolled for Osteoarthritis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05505552 — N/A
Osteoarthritis Research Study Groups: Vitamin K, Placebo
Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05505552 — N/A
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505552 — N/A
~24 spots leftby Dec 2025
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