The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3

NCT ID: NCT06142136

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-28

Study Completion Date

2021-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D3 Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D3 sublingual sprayable microemulsion.

Total participants: 34 participants Duration: 30 days.

Group Type ACTIVE_COMPARATOR

Vitamin D substitution with sublingual sprayable microemulsion.

Intervention Type DIETARY_SUPPLEMENT

Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.

Vitamin D3 oil droplets.

Total participants: 33 participants Duration: 30 days.

Group Type ACTIVE_COMPARATOR

Vitamin D substitution with oil droplets

Intervention Type DIETARY_SUPPLEMENT

Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.

Vitamin D3 capsules.

Total participants: 32 participants Duration: 30 days.

Group Type ACTIVE_COMPARATOR

Vitamin D substitution with capsules

Intervention Type DIETARY_SUPPLEMENT

Participants received capsules of vitamin D3 4000 IU daily for 30 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D substitution with sublingual sprayable microemulsion.

Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D substitution with oil droplets

Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D substitution with capsules

Participants received capsules of vitamin D3 4000 IU daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Vitamin D3 level in the blood below 30 ng/ml.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pauls Stradins Clinical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valdis Pirags, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pauls Stradins Clinical University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pauls Stradins Clinical Univeristy Hospital

Riga, , Latvia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Latvia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

250321-6L

Identifier Type: -

Identifier Source: org_study_id