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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

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: single administration of 100.000 I.U. vitamin D Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: cholecalciferol

Placebo Comparator: subcutaneous placebo
subcutaneous 0.9% sodium chloride
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845142


Locations
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Germany
Dpt of Dermatology and Allergology, Charité University Medicine Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Margitta Worm
Investigators
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Principal Investigator: Margitta Worm, Prof Charite University, Berlin, Germany
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Responsible Party: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01845142    
Other Study ID Numbers: ViDImmun
2012-003217-33 ( EudraCT Number )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by Margitta Worm, Charite University, Berlin, Germany:
vitamin D
vitamin D deficiency
immune cells
pharmacokinetic
< 50 nmol/L 25(OH)D serum concentration
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents