Vitamin D and Grass Pollen Specific Immunotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany Identifier:
First received: November 1, 2011
Last updated: April 24, 2013
Last verified: April 2013

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
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
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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

No publications provided

Responsible Party: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany Identifier: NCT01466465     History of Changes
Other Study ID Numbers: ProGIT, 2010-021775-80
Study First Received: November 1, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 29, 2015