NCT01845142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

April 24, 2013

Last Update Submit

June 24, 2015

Conditions

Vitamin D Deficiency

Keywords

vitamin Dvitamin D deficiencyimmune cellspharmacokinetic< 50 nmol/L 25(OH)D serum concentration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Characterize vitamin D-responding myeloid immune cells

    up to 3 months

  • Impact of vitamin D on specific humoral memory

    up to 3 months

  • Vitamin D pharmacokinetics

    up to 3 months

  • Characterize vitamin D-responsive T cells

    up to 3 months

Study Arms (4)

intramuscular 100.000 I.U. vitamin D3

ACTIVE COMPARATOR

intramuscular 100.000 I.U. vitamin D3

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

intramuscular placebo

PLACEBO COMPARATOR

intramuscular 0.9% sodium chloride

Drug: Placebo

subcutaneous 100.000 I.U. vitamin D3

ACTIVE COMPARATOR

subcutaneous 100.000 I.U. vitamin D3

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

subcutaneous placebo

PLACEBO COMPARATOR

subcutaneous 0.9% sodium chloride

Drug: Placebo

Interventions

single administration of 100.000 I.U. vitamin DDRUG
Also known as: cholecalciferol
intramuscular 100.000 I.U. vitamin D3subcutaneous 100.000 I.U. vitamin D3
PlaceboDRUG
intramuscular placebosubcutaneous placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • informed consent
  • yrs
  • hydroxyvitamin D serum below 50 nmol/L
  • women only: effective contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Dermatology and Allergology, Charité University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Margitta Worm, Prof

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 3, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

April 1, 2014

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

DE(1)