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Completed

NCT Number: NCT06142136

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

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.

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Key information

Conditions

Vitamin D3 Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D substitution with sublingual sprayable microemulsion.

Dietary Supplement

Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.

Vitamin D substitution with oil droplets

Dietary Supplement

Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.

Vitamin D substitution with capsules

Dietary Supplement

Participants received capsules of vitamin D3 4000 IU daily for 30 days.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pauls Stradins Clinical University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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