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Vitamin Supplement
Vitamin K2 + D3 for Post-COVID Syndrome
N/A
Waitlist Available
Led By Grace McComsey, MD, FIDSA
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia is patient reported history.
All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, week 24
Awards & highlights
Study Summary
This trial is for people who have had COVID-19 and are experiencing symptoms 3+ months later. They will take Vitamin K2 and D3 to see if it improves symptoms and the underlying inflammation.
Who is the study for?
This trial is for adults over 18 who've had COVID-19 at least 3 months ago and are now facing lingering symptoms. They must be able to swallow pills, not be pregnant or trying to conceive, and use contraception if necessary. People can't join if they're taking certain vitamin supplements, have cognitive impairments, active cancer treatments, a very low BMI, were recently hospitalized, or have allergies to the vitamins being tested.Check my eligibility
What is being tested?
The study is looking into whether Vitamin K2 (MK-7) and Vitamin D3 can help with long-term symptoms after COVID-19 and reduce inflammation. Participants will take these supplements as part of the research.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects from Vitamin K2 (MK-7) and Vitamin D3 could include digestive discomforts like nausea or diarrhea; however these tend to be mild.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot become pregnant or my partner cannot father a child.
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I am not trying to conceive and will use two forms of birth control if there's a risk of pregnancy.
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I can swallow pills.
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I can read and understand the consent form and have signed it.
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I am not currently experiencing nausea or vomiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Change in Vitamin K2 (MK-7) levels as measured by blood test
Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test
+3 moreSecondary outcome measures
Percent of subjects with >Grade 2 adverse events as measured by patient report
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin K2(MK-7) and Vitamin D3Experimental Treatment2 Interventions
Participants randomized to this group will receive Vitamin K2 (MK-7) and Vitamin D3 by mouth.
Group II: ControlActive Control1 Intervention
Participants to this group will receive no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,107 Total Patients Enrolled
Grace McComsey, MD, FIDSAPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
2 Previous Clinical Trials
524 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take vitamin K or D supplements, but my daily multivitamin's vitamin D is not over 600 UI.I am currently on chemotherapy or immunosuppressive drugs for cancer.I cannot become pregnant or my partner cannot father a child.I am not trying to conceive and will use two forms of birth control if there's a risk of pregnancy.I had COVID-19, confirmed by a test, and have had symptoms for more than 3 months since.I can swallow pills.I can read and understand the consent form and have signed it.I am taking blood thinners like warfarin or coumadin.I am 18 years old or older.I have been taking medication like aspirin or statins regularly for the last 3 months without changing the dose.You have a body mass index (BMI) lower than 18 kg/m2.I have not been hospitalized in the last 28 days.You are allergic to or can't tolerate vitamin K2 or vitamin D3.I am not currently experiencing nausea or vomiting.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Vitamin K2(MK-7) and Vitamin D3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the number of participants in this medical trial?
"Affirmative. According to clinicaltrials.gov, this research project is actively recruiting candidates with an initial post date of June 1st 2022 and a recent update on the 9th of June 2022. 150 patients need to be recruited from one medical facility for participation in this study."
Answered by AI
Are individuals still able to enroll in this clinical experiment?
"Affirmative. Indications from clinicaltrials.gov suggest that this study, first published on June 1st 2022, is now welcoming participants. About 150 individuals must be recruited to one medical centre for the trial to continue progress."
Answered by AI
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