Immunologic Action of a Single Dose Cholecalciferol

Study Overview
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Brief Summary
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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.

Detailed Description
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Vitamin D-deficient individuals will receive once double-blind, placebo controlled 100.000 I.U.vitamin D3 intramuscular or subcutaneous Blood will be taken over time and immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry vitamin D-metabolites will be monitored

Official Title
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Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: single administration of 100.000 I.U. vitamin D
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent 18-60 yrs 25-hydroxyvitamin D serum below 50 nmol/L women only: effective contraception Exclusion Criteria: 25-hydroxyvitamin D serum above 50 nmol/L body-mass index <18 or >30 kg per m2 planned UV-exposure (UV-index > 5) hypersensitivity to vitamin D history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides immobile patients out of normal range on screening visit (calcium,phosphate,creatinin,hematology) psychiatric hospitalization pregnancy / breast-feeding dependency / relationship on sponsor concomitant participation in other clinical trials (30 days before) drug or alcohol abuse lack of compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intramuscular 100.000 I.U. vitamin D3<br>intramuscular 100.000 I.U. vitamin D3 | Drug: single administration of 100.000 I.U. vitamin D<br> <br> * Other names: cholecalciferol;|
| Placebo Comparator: intramuscular placebo<br>intramuscular 0.9% sodium chloride | Drug: Placebo<br> <br> |
| Active Comparator: subcutaneous 100.000 I.U. vitamin D3<br>subcutaneous 100.000 I.U. vitamin D3 | Drug: single administration of 100.000 I.U. vitamin D<br> <br> * Other names: cholecalciferol;|
| Placebo Comparator: subcutaneous placebo<br>subcutaneous 0.9% sodium chloride | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration