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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003217-33 | EudraCT Number |
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Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.
Vitamin D-deficient individuals will receive once
Blood will be taken over time and
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intramuscular 100.000 I.U. vitamin D3 | Active Comparator | intramuscular 100.000 I.U. vitamin D3 |
|
| intramuscular placebo | Placebo Comparator | intramuscular 0.9% sodium chloride |
|
| subcutaneous 100.000 I.U. vitamin D3 | Active Comparator | subcutaneous 100.000 I.U. vitamin D3 |
|
| subcutaneous placebo | Placebo Comparator | subcutaneous 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single administration of 100.000 I.U. vitamin D | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the numbers of vitamin D-responsive B cells after vitamin D administration. | Peripheral B cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry. Vitamin D-responsive B cells will be quantified before and 1 week, 1 month and 3 months after vitamin D administration. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize vitamin D-responding myeloid immune cells | peripheral blood mononuclear cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and monocytes will be characterized phenotypically by flow-cytometry. | up to 3 months |
| Impact of vitamin D on specific humoral memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margitta Worm, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt of Dermatology and Allergology, Charité University Medicine Berlin | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug |
|
The humoral immunoglobulin response against selected endogenous viruses (anti-virus-specific-Ig) over time will be determined before and 3 months after vitamin D administration. |
| up to 3 months |
| Vitamin D pharmacokinetics | Vitamin D-metabolites including 25-hydroxyvitamin D will be determined up to 3 months after administration of a single dose-vitamin D. | up to 3 months |
| Characterize vitamin D-responsive T cells | peripheral T cells will be isolated before, after 1 week, 1 month and 3 months after vitamin D administration and characterized by flow-cytometry according to functional subpopulations. | up to 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |