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

Sponsor

Pauls Stradins Clinical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06142136

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

103.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D3 Deficiency	Dietary Supplement: Vitamin D substitution with sublingual sprayable microemulsion. Dietary Supplement: Vitamin D substitution with oil droplets Dietary Supplement: Vitamin D substitution with capsules	N/A

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

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 28, 2021

Actual Primary Completion Date :

Apr 26, 2021

Actual Study Completion Date :

Apr 26, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in vitamin D level in the blood depending on the received vitamin D form. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pauls Stradins Clinical Univeristy Hospital	Riga		Latvia	LV-1002

Sponsors and Collaborators

Pauls Stradins Clinical University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pauls Stradins Clinical University Hospital

ClinicalTrials.gov Identifier:

NCT06142136

Other Study ID Numbers:

250321-6L

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2023