Immunologic Action of a Single Dose Cholecalciferol

NCT01845142 — Phase 4, Completed, 40 participants, Margitta Worm

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

Registry	NCT01845142, acronym ViDImmun
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: double, basic science
Enrollment	40 (Actual)
Sponsor	Margitta Worm (Other)
Conditions	Vitamin D Deficiency
Interventions	single administration of 100.000 I.U. vitamin D, Placebo (Drug)
Dates	start 2013-02-01, primary completion 2013-05-01, completion 2014-04-01, first posted 2013-05-03, last updated 2015-06-25
Locations	1 site in Germany

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
intramuscular 100.000 I.U. vitamin D3	Active comparator	Drug: single administration of 100.000 I.U. vitamin D	intramuscular 100.000 I.U. vitamin D3
intramuscular placebo	Placebo comparator	Drug: Placebo	intramuscular 0.9% sodium chloride
subcutaneous 100.000 I.U. vitamin D3	Active comparator	Drug: single administration of 100.000 I.U. vitamin D	subcutaneous 100.000 I.U. vitamin D3
subcutaneous placebo	Placebo comparator	Drug: Placebo	subcutaneous 0.9% sodium chloride

single administration of 100.000 I.U. vitamin D (Drug), also known as cholecalciferol
Placebo (Drug)

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Dpt of Dermatology and Allergology, Charité University Medicine Berlin	Berlin, State of Berlin	Germany

+Investigators

Margitta Worm, Prof, Principal investigator, Charite University, Berlin, Germany

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