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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 sublingual sprayable microemulsion. | Active Comparator | Total participants: 34 participants Duration: 30 days. |
|
| Vitamin D3 oil droplets. | Active Comparator | Total participants: 33 participants Duration: 30 days. |
|
| Vitamin D3 capsules. | Active Comparator | Total participants: 32 participants Duration: 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D substitution with sublingual sprayable microemulsion. | Dietary Supplement | Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valdis Pirags, MD, PhD | Pauls Stradins Clinical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pauls Stradins Clinical Univeristy Hospital | Riga | LV-1002 | Latvia |
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| 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. |
|
| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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