NCT05502068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 15, 2022

Last Update Submit

August 15, 2022

Conditions

COVID-19Vitamin D Deficiency

Keywords

COVID-19CRPVitamin D insufficiencyVitamin D spray

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluating the effects of a sprayable microemulsion of cholecalciferol on inflammatory markers in the blood of COVID-19 patients

    Month 1-4

Study Arms (2)

Vitamin D 25 (OH) 12000 IU, Sublingual sprayable microemulsion

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

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

PlaceboVitamin D 25 (OH) 12000 IU, Sublingual sprayable microemulsion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

Location

MeSH Terms

Conditions

COVID-19Vitamin D Deficiency

Interventions

hydroxide ion

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Valdis Pirags, MD, PhD

    Pauls Stradins Clinical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 16, 2022

Study Start

February 1, 2021

Primary Completion

March 31, 2021

Study Completion

June 9, 2021

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)