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

November 20, 2023 updated by: Pauls Stradins Clinical University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D3 sublingual sprayable microemulsion.
Total participants: 34 participants Duration: 30 days.
Dietary supplement: Vitamin D substitution with sublingual sprayable microemulsion.
Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.
Active Comparator: Vitamin D3 oil droplets.
Total participants: 33 participants Duration: 30 days.
Dietary supplement: Vitamin D substitution with oil droplets
Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.
Active Comparator: Vitamin D3 capsules.
Total participants: 32 participants Duration: 30 days.
Dietary supplement: Vitamin D substitution with capsules
Participants received capsules of vitamin D3 4000 IU daily for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pauls Stradins Clinical University Hospital

Investigators

  • Principal Investigator: Valdis Pirags, MD, PhD, Pauls Stradins Clinical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2021

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250321-6L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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