Immunologic Action of a Single Dose Cholecalciferol

Vitamin D Deficiency Clinical Trial

— ViDImmun  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845142
• Other study ID #: ViDImmun
• Secondary ID: 2012-003217-33
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2013
• Last updated: June 24, 2015
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• single administration of 100.000 I.U. vitamin D

• Placebo

Locations

Country	Name	City	State
Germany	Dpt of Dermatology and Allergology, Charité University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Margitta Worm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No