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Completed

NCT Number: NCT01845142

Immunologic Action of a Single Dose Cholecalciferol

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dpt of Dermatology and Allergology, Charité University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single administration of 100.000 I.U. vitamin D

Drug

Other names: cholecalciferol

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Margitta Worm

Other

Registry information

Official study title

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

Acronym: ViDImmun

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 3, 2013
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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