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Vitamin D and Grass Pollen Specific Immunotherapy

This study has been completed.
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany Identifier:
First received: November 1, 2011
Last updated: June 24, 2015
Last verified: June 2015
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.

Condition Intervention Phase
Allergic Rhinoconjunctivitis Drug: Cholecalciferol Other: middle-chain fatty acids (carrier) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Margitta Worm, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo [ Time Frame: three years ]

Enrollment: 35
Study Start Date: October 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vigantol Drug: Cholecalciferol
given orally, once daily, before grass pollen season
Other Name: Vitamin D
Placebo Comparator: neutral oil (vigantol carrier) Other: middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Other Name: neutral oil


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • written informed consent
  • 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:

  • current specific immunotherapy
  • instable allergic asthma
  • pregnancy and lactation
  • treatment with immunomodulators or immunosuppressive drugs
  • sarcoidosis, chronic diseases, malignancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01466465

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Worm Margitta, MD, Prof. Charite University, Berlin, Germany
  More Information

Responsible Party: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany Identifier: NCT01466465     History of Changes
Other Study ID Numbers: ProGIT
2010-021775-80 ( EudraCT Number )
Study First Received: November 1, 2011
Last Updated: June 24, 2015

Keywords provided by Margitta Worm, Charite University, Berlin, Germany:
Vitamin D
Grass pollen
allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on July 19, 2017