Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers

Study Overview
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Brief Summary
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The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status

Detailed Description
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It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

Official Title
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Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail

Conditions
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Deficiency of Vitamin D3

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers age between 18 and 70 years informed consent Exclusion Criteria: use of antihypertensive medication use of vitamin d or calcium supplements known renal, inflammatory or malignant diseases hypercalcemia or hypercalciuria participation in other clinical studies use of tanning booths during the study pregnancy or lactating period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>cholecalciferol 20 µg per day for 12 weeks | Dietary Supplement: Vitamin D3<br>* daily dosage of 20 µg Vitamin D3 for 12 weeks<br>* Other names: cholecalciferol;|
| No Intervention: Placebo<br>Placebo for 12 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D3 | major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group | after 12 weeks of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atherosclerotic risk factors | It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids. | after 12 weeks of supplementation | 
| inflammation | It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor | after 12 weeks of supplementation | 
| hyperlipidemia | It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor | after 12 weeks of supplementation |