Status:
COMPLETED
Immunologic Action of a Single Dose Cholecalciferol
Lead Sponsor:
Margitta Worm
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 on...
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...
Eligibility Criteria
Inclusion
- informed consent
- 18-60 yrs
- 25-hydroxyvitamin D serum below 50 nmol/L
- women only: effective contraception
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01845142
Start Date
February 1 2013
End Date
April 1 2014
Last Update
June 25 2015
Active Locations (1)
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1
Dpt of Dermatology and Allergology, Charité University Medicine Berlin
Berlin, State of Berlin, Germany, 10117