Vitamin D Deficiency
Conditions
Keywords
vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration
Brief summary
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
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
Interventions
DRUGsingle administration of 100.000 I.U. vitamin D
DRUGPlacebo
Sponsors
Margitta Worm
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the numbers of vitamin D-responsive B cells after vitamin D administration. | up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize vitamin D-responding myeloid immune cells | up to 3 months | 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. |
| Impact of vitamin D on specific humoral memory | up to 3 months | 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. |
| Vitamin D pharmacokinetics | up to 3 months | Vitamin D-metabolites including 25-hydroxyvitamin D will be determined up to 3 months after administration of a single dose-vitamin D. |
| Characterize vitamin D-responsive T cells | up to 3 months | 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. |
Countries
Germany
Outcome results
None listed