Immunologic Action of a Single Dose Cholecalciferol (ViDImmun)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Placebo; Drug: single administration of 100.000 I.U. vitamin D

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Dpt of Dermatology and Allergology, Charité University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intramuscular 100.000 I.U. vitamin D3; intramuscular 100.000 I.U. vitamin D3	Drug: single administration of 100.000 I.U. vitamin D; Other Names: cholecalciferol
Placebo Comparator: intramuscular placebo; intramuscular 0.9% sodium chloride	Drug: Placebo
Active Comparator: subcutaneous 100.000 I.U. vitamin D3; subcutaneous 100.000 I.U. vitamin D3	Drug: single administration of 100.000 I.U. vitamin D; Other Names: cholecalciferol
Placebo Comparator: subcutaneous placebo; subcutaneous 0.9% sodium chloride	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Margitta Worm
• Investigators: Principal Investigator: Margitta Worm, Prof, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetic; vitamin D; vitamin D deficiency; immune cells; < 50 nmol/L 25(OH)D serum concentration
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ViDImmun; 2012-003217-33 (EudraCT Number)