An interventional study of Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion in COVID-19 and Vitamin D Deficiency, sponsored by Pauls Stradins Clinical University Hospital. Completed at 1 site in Latvia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Pauls Stradins Clinical University Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 102 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
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
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
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.
Time frame: month 1-4
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.
Time frame: Month 1-4
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Pauls Stradins Clinical University Hospital