Vitamin D3 Deficiency
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTVitamin D substitution with sublingual sprayable microemulsion.
Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.
DIETARY_SUPPLEMENTVitamin D substitution with oil droplets
Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.
DIETARY_SUPPLEMENTVitamin D substitution with capsules
Participants received capsules of vitamin D3 4000 IU daily for 30 days.
Sponsors
Pauls Stradins Clinical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Latvia
Outcome results
None listed