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

Vitamin D3 Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06142136
• Other study ID #: 250321-6L
• Status: Completed
• Phase: N/A
• Start date: March 28, 2021
• Est. completion date: April 26, 2021

Study information

• Verified date: March 2021
• Source: Pauls Stradins Clinical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D3 Deficiency

Intervention

Dietary Supplement:
• Vitamin D substitution with sublingual sprayable microemulsion.
Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.
• Vitamin D substitution with oil droplets
Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.
• Vitamin D substitution with capsules
Participants received capsules of vitamin D3 4000 IU daily for 30 days.

Locations

Country	Name	City	State
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Pauls Stradins Clinical University Hospital

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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