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

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

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.

It had two arms (groups): Vitamin K2(MK-7) and Vitamin D3 (experimental) and Control (no intervention).

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

Participants to this group will receive no intervention.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 151 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: subjects unable to consent due to language barrier or cognitive impairment; subject receiving vitamin k antagonists (e.g. warfarin, coumadin); presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Vitamin D, K2, Magnesium and Zinc was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-06-01 with completion listed for 2024-04-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 1 secondary outcome, for example Percent of subjects with >Grade 2 adverse events as measured by patient report.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 151 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.