COVID-19NCT05502068
The Effects of a Sublingual Sprayable Microemulsion of Vitamin D on Inflammatory Markers in COVID-19 Patients
A study testing Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion in people with COVID-19 and Vitamin D Deficiency, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Vitamin D Deficiency
- What is being tested?
- Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Feb 2021to 9 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 and over
- Vitamin D level below 30 ng/ml
- Positive SARS-CoV-2 test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion
- Keywords
- COVID-19, CRP, Vitamin D insufficiency, Vitamin D spray
- Medical subject headings
- COVID-19, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Month 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Feb 2021
- Primary completion31 Mar 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valdis Pirags, MD, PhD, Principal investigator, Pauls Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502068
- Sponsor's protocol ID
- 2021sunD3LYLmicroTMSARS-CoV-2
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05502068
- Acronym / sponsor ID
- 2021sunD3LYLmicroTMSARS-CoV-2
- Conditions
- COVID-19, Vitamin D Deficiency
- Keywords
- COVID-19, CRP, Vitamin D insufficiency, Vitamin D spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 25 (OH) 12000 IU, Sublingual sprayable microemulsion | Experimental | Dietary Supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsionVitamin 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 |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsionPlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged 18 and over
- Vitamin D level below 30 ng/ml
- Positive SARS-CoV-2 test
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsionThis 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 | Dietary supplement | Placebo, Vitamin D 25 (OH) 12000 IU, Sublingual sprayable microemulsion |
Primary outcome
Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients
Time frame: month 1-4
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.
1 secondary outcome
Evaluating the effects of a sprayable microemulsion of cholecalciferol on inflammatory markers in the blood of COVID-19 patients
Time frame: Month 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valdis Pirags, MD, PhD principal investigator
Pauls Stradins Clinical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D 25 (OH) 12000 IU in the form of a sublingual sprayable microemulsion in people with COVID-19 and Vitamin D Deficiency, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the effects of a sprayable microemulsion of cholecalciferol on vitamin D levels in the blood of COVID-19 patients (time frame: month 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.