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CompletedNCT05356936Updated Sep 27, 2024

Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology and Inflammatory Biomarkers

An interventional study of Vitamin K2 (MK-7) and Vitamin D3 in Post-acute COVID-19 Syndrome, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Post-acute COVID-19 Syndrome

Keywords

  • Vitamin K2 (MK-7) supplementation
  • Vitamin D3 supplementation
  • Inflammatory biomarkers
03

In context

Post-Acute COVID-19 Syndrome

520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.

This study's enrollment of 151 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (actual)

Study arms

  • Experimental
    Vitamin K2(MK-7) and Vitamin D3

    Participants randomized to this group will receive Vitamin K2 (MK-7) and Vitamin D3 by mouth.

    Dietary Supplement: Vitamin K2 (MK-7) · Dietary Supplement: Vitamin D3

  • No intervention
    Control

    Participants to this group will receive no intervention.

Interventions

  • Dietary supplementVitamin K2 (MK-7)

    Participants will receive Vitamin K2 (MK-7) daily by mouth.

  • Dietary supplementVitamin D3

    Participants will receive Vitamin D3 daily by mouth.

06

What researchers measure

Primary outcomes

  1. Change in high-sensitivity C-reactive protein (hs-CRP) as measured by blood test

    Time frame: Baseline, week 12, week 24

  2. Change in interleukin 6 (IL-6) as measured by blood test

    Time frame: Baseline, week 12, week 24

  3. Change in intestinal fatty acid binding protein (Ifab) as measured by blood test

    Time frame: Baseline, week 12, week 24

  4. Change in soluble Tumor Necrosis Factor Receptor II ( sTNF-RII) as measured by blood test

    Time frame: Baseline, week 12, week 24

  5. Change in Vitamin K2 (MK-7) levels as measured by blood test

    Time frame: Baseline, week 12, week 24

  6. Change in Vitamin D3 levels as measured by blood test

    Time frame: Baseline, week 12, week 24

Secondary outcomes

  1. Percent of subjects with >Grade 2 adverse events as measured by patient report

    Time frame: Up to 24 weeks

07

Study locations

1 site
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05356936
Lead sponsor
University Hospitals Cleveland Medical Center
Responsible party
Grace McComsey (Vice President of Research, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
May 2, 2022
Start date
Jun 1, 2022
Primary completion
Apr 1, 2024
Completion
Aug 1, 2024
Last update
Sep 27, 2024

Study contacts

Grace McComsey, MD, FIDSA
principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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