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Vitamin D and Grass Pollen Specific Immunotherapy

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ClinicalTrials.gov Identifier: NCT01466465
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Cholecalciferol Other: middle-chain fatty acids (carrier) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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




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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466465


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

Responsible Party: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01466465     History of Changes
Other Study ID Numbers: ProGIT
2010-021775-80 ( EudraCT Number )
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents