Deficiency of Vitamin D3
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
daily dosage of 20 µg Vitamin D3 for 12 weeks
Sponsors
German Federal Ministry of Education and Research
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 25-hydroxyvitamin D3 | after 12 weeks of supplementation | major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| atherosclerotic risk factors | after 12 weeks of supplementation | 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. |
| inflammation | after 12 weeks of supplementation | 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 |
| hyperlipidemia | after 12 weeks of supplementation | 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 |
Countries
Germany
Outcome results
None listed