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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin D3 Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D substitution with sublingual sprayable microemulsion.
* Dietary Supplement: Vitamin D substitution with oil droplets
* Dietary Supplement: Vitamin D substitution with capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |