Vitamin D3 DeficiencyNCT06142136
The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3
A study testing Vitamin D substitution with sublingual sprayable microemulsion., Vitamin D substitution with oil droplets and Vitamin D substitution with capsules in people with Vitamin D3 Deficiency, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial summary
The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D3 Deficiency
- What is being tested?
- Vitamin D substitution with sublingual sprayable microemulsion., Vitamin D substitution with oil droplets and Vitamin D substitution with capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteLatvia
- Study dates
- 28 Mar 2021to 26 Apr 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vitamin D3 level in the blood below 30 ng/ml.
Who cannot join
- Celiac disease, Crohn's disease, ulcerative colitis, autoimmune gastritis.
- Patients with mental health problems.
- 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 Randomised Comparative Study of the Effect of LYL Love Your Life ® sunD3 LYL Micro™ Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3 - Oral Oil Droplets and Capsules
The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.
Read the detailed description
This randomized comparative study was performed in Liepaja, Latvia, on 99 outpatients, with vitamin D levels below 30 ng/ml. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Before intervention blood samples were taken to determine vitamin D3 level, creatinine, and GFR, each participant received vitamin D3 4000 IU daily for 30 days. After that blood test was performed again, to measure changes in vitamin D3 levels in the blood. Participants answered the questionnaire to collect information about things that might affect vitamin D3 levels, such as dietary habits, physical activities, usage of sunscreen, compliance, etc.
- Conditions
- Vitamin D3 Deficiency
- Being tested
- Vitamin D substitution with sublingual sprayable microemulsion., Vitamin D substitution with oil droplets, Vitamin D substitution with capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D substitution with sublingual sprayable microemulsion.Dietary supplement
Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.
Vitamin D substitution with oil dropletsDietary supplement
Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.
Vitamin D substitution with capsulesDietary supplement
Participants received capsules of vitamin D3 4000 IU daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 sublingual sprayable microemulsion. | Active comparator | Total participants: 34 participants Duration: 30 days. Receives: Dietary Supplement: Vitamin D substitution with sublingual sprayable microemulsion. |
| Vitamin D3 oil droplets. | Active comparator | Total participants: 33 participants Duration: 30 days. Receives: Dietary Supplement: Vitamin D substitution with oil droplets |
| Vitamin D3 capsules. | Active comparator | Total participants: 32 participants Duration: 30 days. Receives: Dietary Supplement: Vitamin D substitution with capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vitamin D level in the blood depending on the received vitamin D form.
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 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start28 Mar 2021
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D3 DeficiencyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 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
- NCT06142136
- Sponsor's protocol ID
- 250321-6L
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparative Study of the Effect of LYL Love Your Life ® sunD3 LYL Micro™ Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3 - Oral Oil Droplets and Capsules
- ClinicalTrials.gov ID
- NCT06142136
- Acronym / sponsor ID
- 250321-6L
- Conditions
- Vitamin D3 Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 21 Nov 2023 (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.
The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.
Detailed description
This randomized comparative study was performed in Liepaja, Latvia, on 99 outpatients, with vitamin D levels below 30 ng/ml. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Before intervention blood samples were taken to determine vitamin D3 level, creatinine, and GFR, each participant received vitamin D3 4000 IU daily for 30 days. After that blood test was performed again, to measure changes in vitamin D3 levels in the blood. Participants answered the questionnaire to collect information about things that might affect vitamin D3 levels, such as dietary habits, physical activities, usage of sunscreen, compliance, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 sublingual sprayable microemulsion. | Active comparator | Dietary Supplement: Vitamin D substitution with sublingual sprayable microemulsion.Total participants: 34 participants Duration: 30 days. |
| Vitamin D3 oil droplets. | Active comparator | Dietary Supplement: Vitamin D substitution with oil dropletsTotal participants: 33 participants Duration: 30 days. |
| Vitamin D3 capsules. | Active comparator | Dietary Supplement: Vitamin D substitution with capsulesTotal participants: 32 participants Duration: 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vitamin D3 level in the blood below 30 ng/ml.
Key exclusion criteria (6 listed)
- Celiac disease, Crohn's disease, ulcerative colitis, autoimmune gastritis.
- Patients with mental health problems.
- 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 substitution with sublingual sprayable microemulsion.Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days. | Dietary supplement | Vitamin D3 sublingual sprayable microemulsion. |
| Vitamin D substitution with oil dropletsParticipants received oil droplets of vitamin D3 4000 IU daily for 30 days. | Dietary supplement | Vitamin D3 oil droplets. |
| Vitamin D substitution with capsulesParticipants received capsules of vitamin D3 4000 IU daily for 30 days. | Dietary supplement | Vitamin D3 capsules. |
Primary outcome
Changes in vitamin D level in the blood depending on the received vitamin D form.
Time frame: 30 days
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 30 days.
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 21 Nov 2023.
- Individual participant dataSharing planned: No
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 substitution with sublingual sprayable microemulsion., Vitamin D substitution with oil droplets and Vitamin D substitution with capsules in people with Vitamin D3 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 1 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 21 Nov 2023. 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. 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?
Changes in vitamin D level in the blood depending on the received vitamin D form. (time frame: 30 days). 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 21 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.