Post-acute COVID-19 SyndromeNCT05356936
Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology and Inflammatory Biomarkers
A study testing Vitamin K2 (MK-7) and Vitamin D3 in people with Post-acute COVID-19 Syndrome, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-acute COVID-19 Syndrome
- What is being tested?
- Vitamin K2 (MK-7) and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous COVID-19 infection as documented by a positive Nucleic Acid Amplification Test (NAAT) PCR test or any licensed SARS-CoV-2 antigen test kit and prolonged, recurrent or newly developed symptoms more than 3 months after the positive test result.
- Male or Female age ≥18 years
- Provides written informed consent and is capable of reading and comprehending the informed consent
- Able to swallow pills.
- No active nausea, vomiting
- All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea for 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
- 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.
Who cannot join
- Subjects unable to consent due to language barrier or cognitive impairment.
- Pregnancy/lactation.
- Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
- Subject receiving vitamin K antagonists (e.g. warfarin, coumadin)
- Subject consuming supplements of vitamin K1, K2, or Vitamin D. A daily multivitamin will not be exclusionary as long as vitamin D is not > 600 UI daily.
- Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
Show all 10Show fewer
- BMI <18 kg/m2.
- Allergy or intolerance to vitamin K2 or vitamin D3
- Hospitalization within the previous 28 days.
- Inability or unwillingness of the individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The Investigators are interested in studying the effects of Vitamin K2 (MK-7) and Vitamin D3 supplementation on PASC symptoms and the underlying inflammatory process.
- Conditions
- Post-acute COVID-19 Syndrome
- Being tested
- Vitamin K2 (MK-7), Vitamin D3
- Keywords
- Vitamin K2 (MK-7) supplementation, Vitamin D3 supplementation, Inflammatory biomarkers
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 (MK-7)Dietary supplement
Participants will receive Vitamin K2 (MK-7) daily by mouth.
Vitamin D3Dietary supplement
Participants will receive Vitamin D3 daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2(MK-7) and Vitamin D3 | Experimental | Participants randomized to this group will receive Vitamin K2 (MK-7) and Vitamin D3 by mouth. Receives: Dietary Supplement: Vitamin K2 (MK-7); Dietary Supplement: Vitamin D3 |
| Control | No intervention | Participants to this group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test
Measured: Baseline, week 12, week 24
Change in interleukin 6 (IL-6) as measured by blood test
Measured: Baseline, week 12, week 24
Change in intestinal fatty acid binding protein (Ifab) as measured by blood test
Measured: Baseline, week 12, week 24
Change in soluble Tumor Necrosis Factor Receptor II ( sTNF-RII) as measured by blood test
Measured: Baseline, week 12, week 24
Change in Vitamin K2 (MK-7) levels as measured by blood test
Measured: Baseline, week 12, week 24
Change in Vitamin D3 levels as measured by blood test
Measured: Baseline, week 12, week 24
Secondary outcomes (1)
Percent of subjects with >Grade 2 adverse events as measured by patient report
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jun 2022
- Primary completion1 Apr 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
- Investigators
- Grace McComsey, MD, FIDSA, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356936
- Sponsor's protocol ID
- STUDY20220109
- Status last verified
- Sep 2024
- First submitted
- 26 Apr 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology and Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT05356936
- Acronym / sponsor ID
- STUDY20220109
- Conditions
- Post-acute COVID-19 Syndrome
- Keywords
- Vitamin K2 (MK-7) supplementation, Vitamin D3 supplementation, Inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants are being asked to take part in this research study because they have had a previous diagnosis (at least 3 months ago) of COVID-19 and are experiencing persistent, recurrent or even new symptoms, i.e. post-acute sequelae of SARS-CoV-2 (PASC). The Investigators are interested in studying the effects of Vitamin K2 (MK-7) and Vitamin D3 supplementation on PASC symptoms and the underlying inflammatory process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2(MK-7) and Vitamin D3 | Experimental | Dietary Supplement: Vitamin K2 (MK-7), Dietary Supplement: Vitamin D3Participants randomized to this group will receive Vitamin K2 (MK-7) and Vitamin D3 by mouth. |
| Control | No intervention | –Participants to this group will receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previous COVID-19 infection as documented by a positive Nucleic Acid Amplification Test (NAAT) PCR test or any licensed SARS-CoV-2 antigen test kit and prolonged, recurrent or newly developed symptoms more than 3 months after the positive test result.
- Male or Female age ≥18 years
- Provides written informed consent and is capable of reading and comprehending the informed consent
- Able to swallow pills.
- No active nausea, vomiting
Key exclusion criteria (10 listed)
- Subjects unable to consent due to language barrier or cognitive impairment.
- Pregnancy/lactation.
- Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
- Subject receiving vitamin K antagonists (e.g. warfarin, coumadin)
- Subject consuming supplements of vitamin K1, K2, or Vitamin D. A daily multivitamin will not be exclusionary as long as vitamin D is not > 600 UI daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2 (MK-7)Participants will receive Vitamin K2 (MK-7) daily by mouth. | Dietary supplement | Vitamin K2(MK-7) and Vitamin D3 |
| Vitamin D3Participants will receive Vitamin D3 daily by mouth. | Dietary supplement | Vitamin K2(MK-7) and Vitamin D3 |
Primary outcome
Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test
Time frame: Baseline, week 12, week 24
Change in interleukin 6 (IL-6) as measured by blood test
Time frame: Baseline, week 12, week 24
Change in intestinal fatty acid binding protein (Ifab) as measured by blood test
Time frame: Baseline, week 12, week 24
Change in soluble Tumor Necrosis Factor Receptor II ( sTNF-RII) as measured by blood test
Time frame: Baseline, week 12, week 24
Change in Vitamin K2 (MK-7) levels as measured by blood test
Time frame: Baseline, week 12, week 24
Change in Vitamin D3 levels as measured by blood test
Time frame: Baseline, week 12, week 24
1 secondary outcome
Percent of subjects with >Grade 2 adverse events as measured by patient report
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace McComsey, MD, FIDSA principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 (MK-7) and Vitamin D3 in people with Post-acute COVID-19 Syndrome, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test (time frame: Baseline, week 12, week 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.