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
PHASE2
35 participants
INTERVENTIONAL
2011-10-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vigantol
Cholecalciferol
given orally, once daily, before grass pollen season
neutral oil (vigantol carrier)
middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Interventions
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Cholecalciferol
given orally, once daily, before grass pollen season
middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* relative Vitamin D deficiency
* clinical relevant grass pollen allergy
* positive intradermal test with grass pollen
* forced expiratory volume at one second (FEV1) \> 70%
Exclusion Criteria
* instable allergic asthma
* pregnancy and lactation
* treatment with immunomodulators or immunosuppressive drugs
* sarcoidosis, chronic diseases, malignancy
18 Years
55 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Margitta Worm
Prof. Dr. med.
Principal Investigators
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Worm Margitta, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
Berlin, , Germany
Countries
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Other Identifiers
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2010-021775-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ProGIT
Identifier Type: -
Identifier Source: org_study_id
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