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

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: Vitamin D3 Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D substitution with sublingual sprayable microemulsion.; Dietary supplement: Vitamin D substitution with oil droplets; Dietary supplement: Vitamin D substitution with capsules

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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.	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

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

Study record dates

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: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• 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