Clinical trial NCT05502068: The Effects of a Sublingual Sprayable Microemulsion of Vitamin D on Inflammatory Markers in COVID-19 Patients
Official title: A Randomized, Placebo-controlled, Independent Study of the Positive, Quantifiable Effects of Sublingual Spray LYL Love Your Life® sunD3 LYLmicro™ (LYLmicro™) on Blood Levels of Vitamin D3 and Inflammatory Markers in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Vitamin D Deficiency
Keywords: COVID-19
CRP
Vitamin D insufficiency
Vitamin D spray
Lead sponsor: Pauls Stradins Clinical University Hospital
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups. Vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) is given three times daily after breakfast, lunch, and dinner (daily dose 12,000 IU) to patients with blood vitamin D levels below 30 ng/ml. The control (placebo) group recieves a placebo spray in the same daily regimen.

Detailed description: This placebo-controlled five-day study will be performed on 100 hospitalized COVID-19 patients with vitamin D insufficiency randomized into two groups.

The aim of this study is to investigate the impact of the high dose vitamin D supplementation on laboratory markers of systemic inflammation such as CRP, ferritin and IL-6 in hospitalized patients with COVID-19. The blood samples are analyzed at the Joint Laboratory of the Pauls Stradins Clinical Univesity Hospital. Patients with confirmed SARS-CoV2 infection (PCR) will be randomly divided into two groups: the intervention group receives vitamin D in the form of a sublingual sprayable microemulsion (LYL love your life® sunD3 LYLmicro™) of 4,000 IU three times daily after breakfast, lunch and dinner; the control group receives the same regimen of placebo spray.

A total of 100 inpatients will be selected for the study. All patients will receive standard care for COVID-19 and existing comorbidities (diabetes, arterial hypertension, etc) according to hospital-approved protocol. The primary outcome is defined as the change in the level of the inflammatory marker and the disease's severity.

Population. Disease severity is defined by the blood oxygen saturation level. Mild clinical manifestation is characterized by SpO2≥94%, moderate 90%≤SpO2\<94% and severe - SpO2\<90%. Age, BMI, GFR, vitamin D and COVID-19 severity are considered as randomization parameters.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 and over
* Vitamin D level below 30 ng/ml
* Positive SARS-CoV-2 test

Exclusion Criteria:

* Patients with mental health problems,
* eGFR ≤30 ml/min,
* Vitamin D level ≥ 30 ng/ml,
* Pregnant women
* Any other illness or condition that the researcher deemed may interfere with the results
* Patients who refuse the studies

Primary outcomes:
measure: Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients
timeFrame: month 1-4
Secondary outcomes:
measure: Evaluating the effects of a sprayable microemulsion of cholecalciferol on inflammatory markers in the blood of COVID-19 patients
timeFrame: Month 1-4
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
Study officials:
affiliation: Pauls Stradins Clinical University Hospital
name: Valdis Pirags, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: