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

NCT ID: NCT05502068

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-06-09

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.

Conditions

COVID-19; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pauls Stradins Clinical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valdis Pirags, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pauls Stradins Clinical University Hospital

Locations

Pauls Stradins Clinical Univeristy Hospital

Riga, , Latvia

Countries

Latvia

Other Identifiers

2021sunD3LYLmicroTMSARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id