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

NCT05356936 | Completed DMC

• 1 other identifier: STUDY20220109
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-acute COVID-19 Syndrome

Keywords

Vitamin K2 (MK-7) supplementation; Vitamin D3 supplementation; Inflammatory biomarkers

Outcome Measures

Primary Outcomes (6)

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

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24

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

  Baseline, week 12, week 24

• Change in Vitamin D3 levels as measured by blood test

  Baseline, week 12, week 24

Secondary Outcomes (1)

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

  Up to 24 weeks

Study Arms (2)

Vitamin K2(MK-7) and Vitamin D3

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants to this group will receive no intervention.

Interventions

Vitamin K2 (MK-7) DIETARY_SUPPLEMENT

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

Vitamin K2(MK-7) and Vitamin D3

Vitamin D3 DIETARY_SUPPLEMENT

Participants will receive Vitamin D3 daily by mouth.

Vitamin K2(MK-7) and Vitamin D3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Vitamin K 2; Cholecalciferol

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Grace McComsey, MD, FIDSA

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Research

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: June 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)