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Immunologic Action of a Single Dose Cholecalciferol (ViDImmun)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01845142
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE April 24, 2013
First Posted Date  ICMJE May 3, 2013
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
Change in the numbers of vitamin D-responsive B cells after vitamin D administration. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
  • Characterize vitamin D-responding myeloid immune cells [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunologic Action of a Single Dose Cholecalciferol
Official Title  ICMJE Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Drug: single administration of 100.000 I.U. vitamin D
    Other Name: cholecalciferol
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: intramuscular 100.000 I.U. vitamin D3
    intramuscular 100.000 I.U. vitamin D3
    Intervention: Drug: single administration of 100.000 I.U. vitamin D
  • Placebo Comparator: intramuscular placebo
    intramuscular 0.9% sodium chloride
    Intervention: Drug: Placebo
  • Active Comparator: subcutaneous 100.000 I.U. vitamin D3
    subcutaneous 100.000 I.U. vitamin D3
    Intervention: Drug: single administration of 100.000 I.U. vitamin D
  • Placebo Comparator: subcutaneous placebo
    subcutaneous 0.9% sodium chloride
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01845142
Other Study ID Numbers  ICMJE ViDImmun
2012-003217-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margitta Worm, Charite University, Berlin, Germany
Study Sponsor  ICMJE Margitta Worm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margitta Worm, Prof Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP