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Immunologic Action of a Single Dose Cholecalciferol (ViDImmun)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
single administration of 100.000 I.U. vitamin D
Placebo
Sponsored by
Margitta Worm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Dpt of Dermatology and Allergology, Charité University Medicine Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

intramuscular 100.000 I.U. vitamin D3

intramuscular placebo

subcutaneous 100.000 I.U. vitamin D3

subcutaneous placebo

Arm Description

intramuscular 100.000 I.U. vitamin D3

intramuscular 0.9% sodium chloride

subcutaneous 100.000 I.U. vitamin D3

subcutaneous 0.9% sodium chloride

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 24, 2013
Last Updated
June 24, 2015
Sponsor
Margitta Worm
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1. Study Identification

Unique Protocol Identification Number
NCT01845142
Brief Title
Immunologic Action of a Single Dose Cholecalciferol
Acronym
ViDImmun
Official Title
Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margitta Worm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, vitamin D deficiency, immune cells, pharmacokinetic, < 50 nmol/L 25(OH)D serum concentration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intramuscular 100.000 I.U. vitamin D3
Arm Type
Active Comparator
Arm Description
intramuscular 100.000 I.U. vitamin D3
Arm Title
intramuscular placebo
Arm Type
Placebo Comparator
Arm Description
intramuscular 0.9% sodium chloride
Arm Title
subcutaneous 100.000 I.U. vitamin D3
Arm Type
Active Comparator
Arm Description
subcutaneous 100.000 I.U. vitamin D3
Arm Title
subcutaneous placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous 0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
single administration of 100.000 I.U. vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
Description
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 Outcome Measure Information:
Title
Characterize vitamin D-responding myeloid immune cells
Description
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
Title
Impact of vitamin D on specific humoral memory
Description
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
Title
Vitamin D pharmacokinetics
Description
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
Title
Characterize vitamin D-responsive T cells
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta Worm, Prof
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Dermatology and Allergology, Charité University Medicine Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Immunologic Action of a Single Dose Cholecalciferol

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