The Effects of a Sublingual Sprayable Microemulsion of Vitamin D on Inflammatory Markers in COVID-19 Patients

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D 25 (OH) 12000 IU, Sublingual sprayable microemulsion; Vitamin D in the form of a sublingual sprayable microemulsion (4000 IU) will be 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 for 5-day intervention	Dietary supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion; This is a prospective, randomized, double blind, and controlled clinical study 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. Patients included in the study will be randomized into two groups and receive a placebo (as a control group) or cholecalciferol administered sublingually for 5 day
Placebo Comparator: Placebo; Placebo will be given to the control group. It will be administrated sublingually, with one spray three times per day for 5 days of the study period	Dietary supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion; This is a prospective, randomized, double blind, and controlled clinical study 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. Patients included in the study will be randomized into two groups and receive a placebo (as a control group) or cholecalciferol administered sublingually for 5 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients	The study's primary outcome is to demonstrate the efficacy of sprayable microemulsion of cholecalciferol on the increase in circulating vitamin D levels over a period of at least 5 days.	month 1-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the effects of a sprayable microemulsion of cholecalciferol on inflammatory markers in the blood of COVID-19 patients	The study's secondary outcome is to demonstrate the efficacy of sprayable microemulsion of cholecalciferol on inflammatory markers (blood cell count, CRP, fibrinogen, IL-6) in COVID-19 patients with vitamin D levels below 29.9 ng/ml.	Month 1-4

Collaborators and Investigators

• Sponsor: Pauls Stradins Clinical University Hospital
• Investigators: Principal Investigator: Valdis Pirags, MD, PhD, Pauls Stradins Clinical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Vitamin D insufficiency; CRP; Vitamin D spray
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; COVID-19; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2021sunD3LYLmicroTMSARS-CoV-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No