Immunologic Action of a Single Dose Cholecalciferol

Margitta Worm40 enrolled

Overview

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 * 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Vitamin D Deficiency

Interventions

single administration of 100.000 I.U. vitamin DDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Dpt of Dermatology and Allergology, Charité University Medicine Berlin

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: up to 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 3 months

Data from ClinicalTrials.gov

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