Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2013-02-28
2014-04-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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intramuscular 100.000 I.U. vitamin D3
intramuscular 100.000 I.U. vitamin D3
single administration of 100.000 I.U. vitamin D
intramuscular placebo
intramuscular 0.9% sodium chloride
Placebo
subcutaneous 100.000 I.U. vitamin D3
subcutaneous 100.000 I.U. vitamin D3
single administration of 100.000 I.U. vitamin D
subcutaneous placebo
subcutaneous 0.9% sodium chloride
Placebo
Interventions
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single administration of 100.000 I.U. vitamin D
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-60 yrs
* 25-hydroxyvitamin D serum below 50 nmol/L
* women only: effective contraception
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Margitta Worm
OTHER
Responsible Party
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Margitta Worm
Prof. Dr. med.
Principal Investigators
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Margitta Worm, Prof
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Dpt of Dermatology and Allergology, Charité University Medicine Berlin
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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2012-003217-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ViDImmun
Identifier Type: -
Identifier Source: org_study_id
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